Cleared Traditional

K961513 - PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET

K961513 is an FDA 510(k) clearance for PROCATH LOCKING PEEL-AWAY INTRODUCER/PE..., manufactured by Ep Medsystems. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K961513 · Ep Medsystems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K961513

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.

DYB Device Classification - Class 2, Special Controls

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 503
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K961513.
BRAUN PERCUTANEOUS INTRODUCER SET
K961745 · B.Braun Medical, Inc. · Sep 1996
PERCUTANEOUS INTRODUCER SET
K961466 · Thomas Medical Products, Inc. · Sep 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
BRAUN HEMOSTASIS INTRODUCERS
K960406 · B.Braun Medical, Inc. · Apr 1996
FIRST PICC INTRODUCER CATHETER
K954906 · Becton Dickinson Vascular Access, Inc. · Apr 1996