Cleared Traditional

K911089 - STEALTH CATHETER SYSTEM

K911089 is an FDA 510(k) clearance for STEALTH CATHETER SYSTEM, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K911089 · Target Therapeutics · Cardiovascular device
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May 1991
Decision
85d
Days
Class 2
Risk

K911089 is an FDA 510(k) clearance for the STEALTH CATHETER SYSTEM. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Target Therapeutics (San Jose, US). The FDA issued a Cleared decision on May 29, 1991 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Target Therapeutics devices

FDA 510(k) Submission Details - K911089

510(k) Number K911089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1991
Decision Date May 29, 1991
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 348
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K911089.
SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA)
K911196 · Schneider Intl., Ltd. · Jun 1991
HEMOSTATIC Y CONNECTOR
K911130 · Thomas Medical Products, Inc. · Jun 1991
GESCO PER-Q-CATH NEEDLE
K911215 · Gesco Intl., Inc. · Jun 1991
ADVANCE 418(TM)
K904984 · Peripheral Systems Group · Apr 1991
MEDI-TECH BALLOON DILATATION CATHETER
K910995 · Boston Scientific Corp · Apr 1991
OPTI-PLAST 5F PTA CATHETERS
K910996 · Vas-Cath, Inc. · Apr 1991