Cleared Special

K022764 - 7F LAUNCHER GUIDE CATHETER

K022764 is the FDA 510(k) clearance for 7F LAUNCHER GUIDE CATHETER by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 7-day FDA review.

K022764 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
7d
Days
Class 2
Risk

K022764 is an FDA 510(k) clearance for the 7F LAUNCHER GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on August 28, 2002 after a review of 7 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 Medtronic Vascular devices

Submission Details

510(k) Number K022764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2002
Decision Date August 28, 2002
Days to Decision 7 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
118d faster than avg
Panel avg: 125d · This submission: 7d
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 589
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K022764.
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552 · Cook, Inc. · Sep 2002
PTA AND PTV
K022722 · NuMED, Inc. · Sep 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K022738 · Guidant Corp. · Sep 2002
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
K021735 · Boston Scientific Scimed, Inc. · Aug 2002
RAPIDO GUIDING CATHETER, 6F MODEL# 6776
K021455 · Guidant Corp. · Aug 2002
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
K021899 · Concentric Medical, Inc. · Jul 2002