Cleared Special

K081394 - PTFE INTERLOCK PEELABLE INTRODUCERS

K081394 is an FDA 510(k) clearance for PTFE INTERLOCK PEELABLE INTRODUCERS, manufactured by Enpath Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 119-day FDA review.

K081394 · Enpath Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
119d
Days
Class 2
Risk

K081394 is an FDA 510(k) clearance for the PTFE INTERLOCK PEELABLE INTRODUCERS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Enpath Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 15, 2008 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081394

510(k) Number K081394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date September 15, 2008
Days to Decision 119 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

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 686
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K081394.
PINNACLE ROII INTRODUCER SHEATH
K082847 · Terumo Medical Corp. · Oct 2008
PRELUDE SHORT SHEATH INTRODUCER
K082063 · Merit Medical Systems, Inc. · Oct 2008
GLIDESHEATH
K082644 · Terumo Medical Corp. · Sep 2008
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K082356 · W.L. Gore & Associates, Inc. · Aug 2008
DESTINATION RENAL GUIDING SHEATH
K081045 · Terumo Medical Corp. · May 2008
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K081046 · Terumo Medical Corp. · May 2008
K081394 · PTFE INTERLOCK PEELABLE INTRODUCERS
Download PDF FDA Summary Enpath Medical, Inc.