Cleared Traditional

PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET (K961513) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961513 · Ep Medsystems · Cardiovascular device
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May 1996
Decision
24d
Days
Class 2
Risk

K961513 is an FDA 510(k) clearance for the PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Ep Medsystems (Berlin, US). The FDA issued a Cleared decision on May 13, 1996 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ep Medsystems devices

Submission Details

510(k) Number K961513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1996
Decision Date May 13, 1996
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 217
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K961513.
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K962746 · Cordis Corp. · Oct 1996
INPUT TUOHY-BORST LOCKING DEVICE
K960445 · C.R. Bard, Inc. · Aug 1996
INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)
K961135 · C.R. Bard, Inc. · Apr 1996
TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
K955785 · C.R. Bard, Inc. · Mar 1996
CORDIS BRITE TIP SHEATH INTRODUCER
K954595 · Cordis Corp. · Dec 1995