Cleared Traditional

K911605 - TRACKER UNIBODY

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

K911605 · Target Therapeutics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 292
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