Cleared Traditional

K915895 - STEALTH DILATION CATHETER SYSTEM (MODIFIED)

K915895 is an FDA 510(k) clearance for STEALTH DILATION CATHETER SYSTEM (MODIFIED), 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 323-day FDA review.

K915895 · Target Therapeutics · Cardiovascular device
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Jun 1992
Decision
323d
Days
Class 2
Risk

K915895 is an FDA 510(k) clearance for the STEALTH DILATION CATHETER SYSTEM (MODIFIED). 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 June 4, 1992 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K915895

510(k) Number K915895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1991
Decision Date June 04, 1992
Days to Decision 323 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
198d slower than avg
Panel avg: 125d · This submission: 323d
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 K915895.
SCIMED SIDEWINDER TUOHY-BORST Y-ADAPTER
K921577 · Scimed Life Systems, Inc. · Oct 1992
TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH.
K921856 · Schneider Intl., Ltd. · Jul 1992
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL
K921943 · Schneider Intl., Ltd. · Jun 1992
ULTRA-THIN
K920547 · Boston Scientific Corp · May 1992
PROFLEX 5
K915168 · Peripheral Systems Group · Feb 1992
PTA BALLOON CATHETER
K915349 · Schneider Intl., Ltd. · Feb 1992