Cleared Traditional

K091703 - HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131

K091703 is an FDA 510(k) clearance for HD GUIDE CATHETER, manufactured by Concentric Medical, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K091703 · Concentric Medical, Inc. · Cardiovascular device
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Oct 2009
Decision
126d
Days
Class 2
Risk

K091703 is an FDA 510(k) clearance for the HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 14, 2009 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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

FDA 510(k) Submission Details - K091703

510(k) Number K091703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2009
Decision Date October 14, 2009
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEZ Device Classification - Class 2, Special Controls

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
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 - QEZ Aspiration Thrombectomy Catheter

All 86
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K091703.
ANGIOJET SOLENT OMNI THROMBECTOMY SET
K111182 · Medrad, Inc. · May 2011
MERIT EMBOLECTOMY CATHETER MODEL ASAP100
K100569 · Merit Medical Systems, Inc. · Mar 2011
PRONTO V4 EXTRACTION CATHETER 5.5F
K103405 · Vascular Solutions, Inc. · Dec 2010
ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
K091593 · Possis Medical, Inc. · Jun 2009
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
K090253 · Possis Medical, Inc. · Apr 2009
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
K083784 · Vascular Solutions, Inc. · Mar 2009