Cleared Special

K102176 - FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10

K102176 is an FDA 510(k) clearance for FLEXCATH STEERABLE SHEATH (12 FRENCH), manufactured by Medtronic Cryocath, LP. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Special 510(k) pathway after a 29-day FDA review.

K102176 · Medtronic Cryocath, LP · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
29d
Days
Class 2
Risk

K102176 is an FDA 510(k) clearance for the FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) .... Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Medtronic Cryocath, LP (Kirkland, CA). The FDA issued a Cleared decision on September 1, 2010 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - 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. Low regulatory complexity profile. 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 - K102176

510(k) Number K102176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2010
Decision Date September 01, 2010
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DRA Device Classification - Class 2, Special Controls

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
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 - DRA Catheter, Steerable

All 41
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K102176.
CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM
K120086 · Cardiosolutions · Apr 2012
Z FLEX-270TM STEERABLE SHEATH
K112541 · Great Batch Medical · Feb 2012
STEERABLE GUIDE CATHETER
K112239 · Abbott Vascular · Aug 2011
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
K100789 · Evalve, Inc. · Apr 2010
EVALVE STEERABLE GUIDE CATHETER
K093866 · Evalve, Inc. · Jan 2010
EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
K091596 · Evalve, Inc. · Jul 2009
K102176 · FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
Download PDF FDA Summary Medtronic Cryocath, LP