← Product Code [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB) · K962978

# CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM (K962978)

_Johnson & Johnson Medical, Inc. · DYB · Jan 7, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K962978

## Device Facts

- **Applicant:** Johnson & Johnson Medical, Inc.
- **Product Code:** [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB.md)
- **Decision Date:** Jan 7, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1340
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for Use

The CENTERMARK* Catheter Introducer Sheath with PROTECTIV* 2000 Needle Safety System is designed for percutaneous access for the introduction of catheters and guidewires. The PROTECTIV* 2000 Needle Safety System is designed to reduce needle sticks injuries.

## Device Story

Device consists of catheter introducer sheath and integrated needle safety system; used for percutaneous access for catheter/guidewire placement. Safety system mechanism designed to reduce needle stick injuries during procedure. Used by clinicians in clinical settings. Device facilitates vascular or other percutaneous access; safety feature protects operator from sharps injury.

## Clinical Evidence

Bench testing only; includes biocompatibility, sterility, and system performance testing.

## Technological Characteristics

Catheter introducer sheath; integrated needle safety system. Sterilization method not specified. Materials biocompatible per standard testing.

## Regulatory Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

## Submission Summary (Full Text)

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K962978
July 24, 1996
JAN - 7 1997

510(k) Summary of Safety and Effectiveness

CENTERMARK* Catheter Introducer Sheath
\With PROTECTIV* 2000 Needle Safety System

The CENTERMARK * Catheter Introducer Sheath with PROTECTIV* 2000
Needle Safety System is designed for percutaneous access for the introduction of
catheters and guidewires. The PROTECTIV* 2000 Needle Safety System is
designed to reduce needle sticks injuries.

The introducer sheath portion of the system is the same product that is currently
marketed by JJMI. The Safety system has passed all tests for safety and
effectiveness (i.e. biocompatibility, sterility and system performance).

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K962978](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K962978)

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