Cleared Traditional

K915521 - TRACKER UNIBODY CATH & TRACKER 25 CATH

K915521 is the FDA 510(k) clearance for TRACKER UNIBODY CATH & TRACKER 25 CATH by Target Therapeutics. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 588
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K915521.
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K915777 · Cordis Corp. · Feb 1992
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K913830 · Scimed Life Systems, Inc. · Nov 1991