Cleared Traditional

K934191 - NEW BLUE MAX BALLOON DILATATION CATHETER

K934191 is the FDA 510(k) clearance for NEW BLUE MAX 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 105-day FDA review.

K934191 · Boston Scientific Corp · Cardiovascular device
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Dec 1993
Decision
105d
Days
Class 2
Risk

K934191 is an FDA 510(k) clearance for the NEW BLUE MAX 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 December 9, 1993 after a review of 105 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 Boston Scientific Corp devices

Submission Details

510(k) Number K934191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1993
Decision Date December 09, 1993
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 K934191.
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K933236 · Cordis Corp. · Dec 1993
TYSHAK PERIPHERAL BALLOON DILATION CATHETER
K931009 · NuMED, Inc. · Dec 1993
SCIMED MAVERICK PTA CATHETER
K932537 · Scimed Life Systems, Inc. · Dec 1993
ULTRA THIN BALLOON DILATATION CATHETER
K924320 · Boston Scientific Corp · Nov 1993
ULTRA THIN BALLOON DILATATION CATHETER
K923611 · Boston Scientific Corp · Nov 1993