← Product Code [LIS](/productcode/LIS) · K970341

# MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT (K970341)

_Medtronic PS Medical · LIS · Apr 23, 1997 · HO · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K970341

## Device Facts

- **Applicant:** Medtronic PS Medical
- **Product Code:** [LIS](/productcode/LIS.md)
- **Decision Date:** Apr 23, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Review Panel:** HO
- **Attributes:** Therapeutic

## Indications for Use

The Medtronic PS Medical Rivas™ Vascular Catheter Repair Kit is indicated for the repair of the external segment of a vascular catheter.

## Device Story

Device used for repair of external segments of vascular catheters; composed of silicone elastomer; utilized by clinicians in surgical or clinical settings; restores integrity of damaged vascular access lines; mitigates risks associated with catheter failure; clinical benefit derived from established history of silicone elastomer vascular access products.

## Clinical Evidence

No clinical data provided; safety and efficacy based on clinical history of materials and predicate device performance.

## Technological Characteristics

Materials: Silicone elastomer. Form factor: Repair kit for external vascular catheter segments. Sterilization: Not specified.

## Predicate Devices

- Bard Davol Repair Kit

## Submission Summary (Full Text)

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K970341

# 510(k) Summary
upon which equivalency is claimed
**Medtronic PS Medical Repair Kit**
**Summary of Safety and Efficacy**

APR 23 1997

The determination of safety and efficacy for the Medtronic PS Medical Rivas™ Vascular Catheter Repair Kit is based upon the predicate Bard Davol Repair Kit.

The safety and efficacy of design and indications is based upon years of clinical history with vascular access products fabricated from silicone elastomer. The materials utilized in the Medtronic PS Medical Rivas™ Vascular Catheter Repair Kit have demonstrated clinical *in-vivo* safety and efficacy.

The Bard Davol Repair Kit has proven safe and effective for repair of the external segment of a vascular catheter.

Vascular access products are not free from failure. Complications associated with the use of the device may be similar to those experienced in any other similar surgical procedure:

- Reactions to drugs or anesthetic agents;
- Electrolyte imbalance;
- Allergic reaction to materials;

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.

Based upon the summary above, Medtronic PS Medical determines substantial equivalence and safety and efficacy of the Rivas™ Vascular Catheter Repair Kit based upon the predicate and currently marketed devices.

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**Source:** [https://fda-staging.innolitics.com/device/K970341](https://fda-staging.innolitics.com/device/K970341)

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