← Product Code [LJS](/productcode/LJS) · K960055

# MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 (K960055)

_Pudenz-Schulte Medical Research Corp. · LJS · Sep 30, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K960055

## Device Facts

- **Applicant:** Pudenz-Schulte Medical Research Corp.
- **Product Code:** [LJS](/productcode/LJS.md)
- **Decision Date:** Sep 30, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5970
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Device Story

BioGlide Vascular Catheter, single lumen, is an implanted device used for vascular access. Device is susceptible to complications including catheter malposition, occlusion, fibrin sheath formation, dislodgment, rupture, and exit site necrosis. Systemic risks include infection, sepsis, endocarditis, cardiac arrhythmia, vascular thrombosis, and vessel perforation. Device usage involves surgical procedures under local or general anesthesia. Potential for postural-related occlusion or breakage due to crimping between clavicle and first rib. Clinical management requires monitoring for colonization by pathogens such as Staphylococcus epidermidis, with removal often necessary in cases of infection.

## Regulatory Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

## Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

K960055
SEP 30 1996

# PREMARKET APPROVAL NOTIFICATION CERTIFICATION AND SUMMARY

(To be submitted when claiming equivalence to a Class III device)

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for the BioGlide Vascular Catheter, single lumen. I further certify that I am aware of the types of problems to which the BioGlide Vascular Catheter, single lumen is susceptible and that the following summary of the types and causes of safety and/or effectiveness problems about the BioGlide Vascular Catheter, single lumen is complete and accurate.

Complications associated with the use of the device may be similar to those experienced in any other surgical procedure carried out under local and/or general anesthetic:

- Reactions to drugs or anesthetic agents;
- Electrolyte imbalance;
- Excessive Blood loss;

Local and Systemic Infections are not uncommon with this type of procedure. They are most usually due to organisms that inhabit the skin, particularly *Staphylococcus epidermidis*. However, other pathogens circulating in the blood stream may colonize the device and in the majority of patients require its removal.

Other potential complications are listed:

|  Catheter or cuff erosion through skin | Endocarditis  |
| --- | --- |
|  Catheter malposition, occlusion, fibrin sheath formation at tip, dislodgment, or rupture | Cardiac arrhythmia  |
|  Intolerance reaction to implanted device | Thrombophlebitis  |
|  Vascular thrombosis | Sepsis or infection  |
|  Perforation or laceration of vessels or viscous | Embolus  |
|  Pneumothorax, hemothorax, or hydrothorax | Brachial plexus injury  |
|  Postural related catheter occlusion, damage, or breakage due to catheter crimping between the clavicle and first rib | Hematoma  |
|   | Cardiac tamponade  |
|   | Exit site necrosis  |

A Bibliography or other citation of the materials upon which the above summary is based is found in Attachment 7 of this submission.

Printed name of person required to submit 510(k): Tom Holdych

Signature of person required to submit 510(k): [Handwritten signature]

Title of person submitting 510(k): Director Regulatory Affairs and Quality Assurance

Name of Company: Medtronic PS Medical Corporation

Date: 1/3/96

Page 67 of 67

---

**Source:** [https://fda-staging.innolitics.com/device/K960055](https://fda-staging.innolitics.com/device/K960055)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com