Cleared Traditional

K894105 - TARGET THERAPEUTICS TRACKER LF CATHETER

K894105 is an FDA 510(k) clearance for TARGET THERAPEUTICS TRACKER LF CATHETER, 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 111-day FDA review.

K894105 · Target Therapeutics · Cardiovascular device
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Sep 1989
Decision
111d
Days
Class 2
Risk

K894105 is an FDA 510(k) clearance for the TARGET THERAPEUTICS TRACKER LF CATHETER. 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 September 28, 1989 after a review of 111 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 - K894105

510(k) Number K894105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1989
Decision Date September 28, 1989
Days to Decision 111 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
14d faster than avg
Panel avg: 125d · This submission: 111d
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 K894105.
SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR
K897082 · Schneider Intl., Ltd. · Mar 1990
PSG(TM) EDM(TM) INFUSION CATHETER
K895932 · Peripheral Systems Group · Jan 1990
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989
USCI UNCOATED GUIDING CATHETERS
K894682 · C.R. Bard, Inc. · Sep 1989
USCI PROBING CATHETER
K890152 · C.R. Bard, Inc. · Aug 1989
TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE
K894084 · Target Therapeutics · Aug 1989