Cleared Traditional

K010954 - CONCENTRIC BALLOON GUIDE CATHETER

K010954 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 193-day FDA review.

K010954 · Concentric Medical, Inc. · Cardiovascular device
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Oct 2001
Decision
193d
Days
Class 2
Risk

K010954 is an FDA 510(k) clearance for the CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Moutian View, US). The FDA issued a Cleared decision on October 9, 2001 after a review of 193 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Concentric Medical, Inc. devices

Submission Details

510(k) Number K010954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2001
Decision Date October 09, 2001
Days to Decision 193 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
68d slower than avg
Panel avg: 125d · This submission: 193d
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 K010954.
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · Boston Scientific Corp · Dec 2001
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638 · Guidant Corp. · Dec 2001
STENT SUPPORT GUIDE CATHETER
K010579 · Medtronic Vascular · Nov 2001
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K012913 · C.R. Bard, Inc. · Sep 2001
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
K012050 · Guidant Corp. · Sep 2001
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K012083 · Medtronic Vascular · Aug 2001