Cleared Traditional

K102657 - CONCENTRIC BALLOON GUIDE CATHETER

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

K102657 · Concentric Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 577
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K102657.
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
K103386 · Medtronic, Inc. · Feb 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
MEDTRONIC C315 DELIVERY CATHETER
K101885 · Medtronic, Inc. · Sep 2010
HEADWAY 17 ADVANCED MICROCATHETER
K101542 · MicroVention, Inc. · Aug 2010
OCCLUSION BALLOON CATHETER MODEL OBC
K101877 · Cook, Inc. · Aug 2010