Cleared Traditional

K102657 - CONCENTRIC BALLOON GUIDE CATHETER

K102657 is an FDA 510(k) clearance for CONCENTRIC BALLOON GUIDE CATHETER, manufactured by Concentric Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K102657 · Concentric Medical, Inc. · Cardiovascular device
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Nov 2010
Decision
63d
Days
Class 2
Risk

K102657 is an FDA 510(k) clearance for the CONCENTRIC BALLOON GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on November 17, 2010 after a review of 63 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 Concentric Medical, Inc. devices

FDA 510(k) Submission Details - K102657

510(k) Number K102657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2010
Decision Date November 17, 2010
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
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 781
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K102657.
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
K103534 · Trireme Medical, Inc. · Jan 2011
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
K101659 · Vascular Solutions, Inc. · Dec 2010
SEEKER CROSSING SUPPORT CATHETER
K103367 · Bard Peripheral Vascular, Inc. · Dec 2010
GUIDE CATHETERS AND ACCESSORIES
K101015 · Thomas Medical Products, Inc. · Sep 2010
MEDTRONIC C315 DELIVERY CATHETER
K101885 · Medtronic, Inc. · Sep 2010
HEADWAY 17 ADVANCED MICROCATHETER
K101542 · MicroVention, Inc. · Aug 2010