Cleared Special

K091527 - ADVANCE 35LP LOW PROFILE PTA BALLOON DI...

K091527 is the FDA 510(k) clearance for ADVANCE 35LP LOW PROFILE PTA BALLOON DI... by Cook, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 17-day FDA review.

K091527 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
17d
Days
Class 2
Risk

K091527 is an FDA 510(k) clearance for the ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on June 12, 2009 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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.

View all Cook, Inc. devices

Submission Details

510(k) Number K091527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2009
Decision Date June 12, 2009
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 577
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K091527.
TRAILBLAZER SUPPORT CATHETER
K092299 · Ev3, Inc. · Aug 2009
PIGGYBACK WIRE CONVERTER
K090977 · Vascular Solutions, Inc. · Jun 2009
GOPHER GOLD CATHETER, MODEL 5620
K091345 · Vascular Solutions, Inc. · Jun 2009
HD GUIDE CATHETER
K090335 · Concentric Medical, Inc. · May 2009
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150
K090849 · Ev3, Inc. · May 2009
ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER
K090822 · Cook, Inc. · Apr 2009