← Product Code [FOZ](/productcode/FOZ) · K954428

# SOLOPICC 24 (60CM) 20GA CATHETER (K954428)

_Douglas Medical Products Corp. · FOZ · Mar 28, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K954428

## Device Facts

- **Applicant:** Douglas Medical Products Corp.
- **Product Code:** [FOZ](/productcode/FOZ.md)
- **Decision Date:** Mar 28, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5200
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

The SoloPICC and SoloMidline Peripheral Intravenous catheters are intended to be used for the administration of medications, fluids and nutritional therapy of thirty days or less duration.

## Device Story

SoloPICC and SoloMidline are sterile, single-lumen, radiopaque, flexible intravenous catheters; include PVC female Luer lock adapter, stiffening stylet, and TFX T-Peel™ peelable introducer catheter. Used for short-term (≤30 days) administration of medications, fluids, and nutritional therapy. Operated by clinicians in clinical settings. Catheters facilitate venous access; design ensures compatibility with standard infusion practices. Benefit: provides reliable, temporary vascular access for therapeutic delivery.

## Clinical Evidence

Bench testing only; no clinical data provided. Sterility assurance level 10^-6 per AAMI guidelines; LAL testing per USP guidelines.

## Technological Characteristics

Radiopaque catheter; PVC female Luer lock adapter; stiffening stylet; polyethylene protector; Tyvek/Mylar packaging. Sterilized per AAMI guidelines (10^-6 SAL).

## Regulatory Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

## Predicate Devices

- L-Cath® Intravenous Placement Unit ([K801575](/device/K801575.md))
- Medical Profiles, Inc. Peripheral Intravenous Catheter ([K914378](/device/K914378.md))

## Submission Summary (Full Text)

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{0}

Douglas Medical Products
A SoloPak® Company
K 954428
September 16, 1995
MAR 28 1996

To Whom it may concern:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act and CFR 807.92:

Trade Name - SoloPICC and SoloMidline Peripheral Intravenous Catheter
Common Name - PICC, Peripherally Inserted Central Catheter, Flexible Intravenous Catheter
Classification Name - Percutaneous Intravascular Catheter

The SoloPICC and SoloMidline Peripheral Intravenous catheters are intended to be used for the administration of medications, fluids and nutritional therapy of thirty days or less duration.

The SoloPICC and SoloMidline catheters are sterile, non-pyrogenic, single lumen radiopaque catheters with a PVC female Luer lock adapter. A stiffening stylet is inserted into the female adapter and runs the length of the catheter. The catheter is shrouded in a polyethylene protector and packaged in a printed tyvek\mylar peel pouch. A TFX T-Peel™ peelable introducer catheter is included in the tyvek\mylar package for catheter insertion purposes.

The processes and materials used to manufacture the SoloPICC and SoloMidline catheters are the same or the equivalent of the predicate devices named in this submission. The named predicate devices in this submission were the Luther Medical Products, Inc. L-Cath® Intravenous Placement Unit (K801575) and the Medical Profiles, Inc. Peripheral Intravenous Catheter (K914378). The SoloPICC and SoloMidline catheters are sterilized per AAMI guidelines to a 10 -s sterility assurance level. Each production lot is LAL tested per USP guidelines.

Based on the fact that the SoloPICC and SoloMidline catheters utilize similar and equivalent designs, materials, and components as currently legally marketed products, these products are safe and effective when used as intended.

Sincerely,

Ron Haselhorst
Director of RA\QA
Douglas Medical Products

1840 Industrial Drive, Suite 200, Libertyville, IL 60048 • Telephone: 708-949-7387 • Telefax: 708-949-7388

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**Source:** [https://fda-staging.innolitics.com/device/K954428](https://fda-staging.innolitics.com/device/K954428)

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