Cleared Traditional

K897124 - SMALL VESSEL BALLOON DILATATION CATHETER

K897124 is an FDA 510(k) clearance for SMALL VESSEL BALLOON DILATATION CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K897124 · Boston Scientific Corp · Cardiovascular device
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Jul 1990
Decision
203d
Days
Class 2
Risk

K897124 is an FDA 510(k) clearance for the SMALL VESSEL BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 203 days - an extended review 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: 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.

FDA 510(k) Submission Details - K897124

510(k) Number K897124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date July 17, 1990
Days to Decision 203 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
78d slower than avg
Panel avg: 125d · This submission: 203d
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 404
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K897124.
GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER
K903606 · North American Instrument Corp. · Sep 1990
SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER
K902091 · Schneider Intl., Ltd. · Sep 1990
CATHSCANNER(R) PTA BALLOON DILATATION CATHETER
K902454 · Endosonics Corp. · Aug 1990
HOLLOW MOTOR DRIVE UNIT
K901601 · Devices For Vascular Intervention, Inc. · Jul 1990
MODIFIED IVT PERIPHERAL ATHERECTOMY
K901767 · Intensive Technology, Inc. · Jun 1990
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
K901018 · Boston Scientific Corp · May 1990
K897124 · SMALL VESSEL BALLOON DILATATION CATHETER
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