Cleared Traditional

K082854 - NANOCORSS .014 OTW PTA DILATATION CATHETER

K082854 is an FDA 510(k) clearance for NANOCORSS .014 OTW PTA DILATATION CATHETER, manufactured by Ev3, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K082854 · Ev3, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
66d
Days
Class 2
Risk

K082854 is an FDA 510(k) clearance for the NANOCORSS .014 OTW PTA DILATATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Ev3, Inc. (Plymouth, US). The FDA issued a Cleared decision on December 4, 2008 after a review of 66 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ev3, Inc. devices

FDA 510(k) Submission Details - K082854

510(k) Number K082854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date December 04, 2008
Days to Decision 66 days
Submission Type Traditional
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
59d faster than avg
Panel avg: 125d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 780
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K082854.
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
MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
K082670 · Medtronic, Inc. · Dec 2008
HEADWAY 17 MICROCATHETER
K083343 · MicroVention, Inc. · Dec 2008
VIPERSPHERE PTA BALLOON CATHETER
K083139 · Cardiovascular Systems, Inc. · Nov 2008
NEURON SELECT CATHETER SIZE 070
K083125 · Penumbra, Inc. · Nov 2008