Cleared Special

K082670 - MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET

K082670 is an FDA 510(k) clearance for MODIFICATION TO: ATTAIN PREVAIL 6228CTH..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 80-day FDA review.

K082670 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
80d
Days
Class 2
Risk

K082670 is an FDA 510(k) clearance for the MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on December 4, 2008 after a review of 80 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 - K082670

510(k) Number K082670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date December 04, 2008
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 894
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K082670.
SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER
K082559 · Spectranetics Corp. · Dec 2008
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS
K082561 · Spectranetics Corp. · Dec 2008
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY
K080428 · Medtronic, Inc. · Dec 2008
NANOCORSS .014 OTW PTA DILATATION CATHETER
K082854 · Ev3, Inc. · Dec 2008
HEADWAY 17 MICROCATHETER
K083343 · MicroVention, Inc. · Dec 2008
VIPERSPHERE PTA BALLOON CATHETER
K083139 · Cardiovascular Systems, Inc. · Nov 2008
K082670 · MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
Download PDF FDA Summary Medtronic, Inc.