Cleared Special

K083422 - 6F TAIGA GUIDING CATHETER

K083422 is an FDA 510(k) clearance for 6F TAIGA GUIDING CATHETER, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 79-day FDA review.

K083422 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
79d
Days
Class 2
Risk

K083422 is an FDA 510(k) clearance for the 6F TAIGA GUIDING 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 February 6, 2009 after a review of 79 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.

FDA 510(k) Submission Details - K083422

510(k) Number K083422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2008
Decision Date February 06, 2009
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

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 895
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K083422.
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K083596 · ClearStream Technologies , Ltd. · Mar 2009
BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES
K080987 · Bridgepoint Medical · Feb 2009
ASAHI CORSAIR MICROCATHETER
K083127 · Asahi Intecc Co., Ltd. · Feb 2009
WILDCAT 7F GUIDEWIRE SUPPORT CATHETER
K083313 · Avinger, Inc. · Feb 2009
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
K081878 · LeMaitre Vascular, Inc. · Jan 2009
K083422 · 6F TAIGA GUIDING CATHETER
Download PDF FDA Summary Medtronic Vascular