Cleared Special

K091596 - EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST

K091596 is an FDA 510(k) clearance for EVALVE STEERABLE GUIDE CATHETER, manufactured by Evalve, Inc.. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Special 510(k) pathway after a 30-day FDA review.

K091596 · Evalve, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
30d
Days
Class 2
Risk

K091596 is an FDA 510(k) clearance for the EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Evalve, Inc. (Menlo Park, US). The FDA issued a Cleared decision on July 2, 2009 after a review of 30 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 - K091596

510(k) Number K091596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2009
Decision Date July 02, 2009
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 40
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K091596.
FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
K102176 · Medtronic Cryocath, LP · Sep 2010
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
K100789 · Evalve, Inc. · Apr 2010
EVALVE STEERABLE GUIDE CATHETER
K093866 · Evalve, Inc. · Jan 2010
STEERABLE GUIDE CATHETER
K083793 · Evalve, Inc. · Apr 2009
FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
K081049 · Cryocath Technologies, Inc. · Jun 2008
FLEXCATH STEERABLE SHEATH & DILATOR
K070357 · Cryocath Technologies, Inc. · Dec 2007
K091596 · EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
Download PDF FDA Summary Evalve, Inc.