Cleared Traditional

K915521 - TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED

K915521 is an FDA 510(k) clearance for TRACKER UNIBODY CATH & TRACKER 25 CATH, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K915521 · Target Therapeutics · Cardiovascular device
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Mar 1992
Decision
144d
Days
Class 2
Risk

K915521 is an FDA 510(k) clearance for the TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Target Therapeutics (San Jose, US). The FDA issued a Cleared decision on March 23, 1992 after a review of 144 days - within the typical 510(k) review window.

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 Target Therapeutics devices

FDA 510(k) Submission Details - K915521

510(k) Number K915521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1991
Decision Date March 23, 1992
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 792
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K915521.
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VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · Cook, Inc. · May 1992
RIGHT ATRIAL CATHETER KITS
K920331 · Akcess Medical Products, Inc. · Apr 1992
CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER
K915374 · Cordis Corp. · Feb 1992
CORDIS SHUTTLE CATHETER
K915777 · Cordis Corp. · Feb 1992
ITC GUIDING CATHETER
K913052 · Interventional Therapeutics Corp. · Nov 1991