Cleared Traditional

K897124 - SMALL VESSEL BALLOON DILATATION CATHETER

K897124 is the FDA 510(k) clearance for SMALL VESSEL BALLOON DILATATION CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (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.

View all Boston Scientific Corp devices

Submission Details

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.

Device Classification

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 238
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K897124.
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.
K902317 · Mallinckrodt Medical · Dec 1990
PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
K900094 · Boston Scientific Corp · Oct 1990
MEDI-TECH DILATATION CATHETERS ULTRA THIN II
K897106 · Boston Scientific Corp · Oct 1990
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
K901018 · Boston Scientific Corp · May 1990
LE PTA CATHETER
K894250 · Baxter Healthcare Corp · Mar 1990
EXPANSION OF THE CORDIS PTA DILATATION CATHETER
K894899 · Cordis Corp. · Jan 1990