Cleared Traditional

K911605 - TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES

K911605 is an FDA 510(k) clearance for TRACKER UNIBODY, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K911605 · Target Therapeutics · Cardiovascular device
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Jul 1991
Decision
90d
Days
Class 2
Risk

K911605 is an FDA 510(k) clearance for the TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Target Therapeutics (San Jose, US). The FDA issued a Cleared decision on July 9, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Target Therapeutics devices

FDA 510(k) Submission Details - K911605

510(k) Number K911605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1991
Decision Date July 09, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 408
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K911605.
CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
K914007 · Cordis Corp. · Oct 1991
ACS RX SUPPORT CATHETER
K911957 · Advanced Cardiovascular Systems, Inc. · Sep 1991
SCIMED 7 FR. & 8 FR.
K913364 · Scimed Life Systems, Inc. · Aug 1991
ZEPHYR INFUSION CATHETER
K911560 · Target Therapeutics · Jul 1991
CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER
K911703 · Cordis Corp. · Jun 1991
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
K911367 · Baxter Healthcare Corp · Jun 1991