Cleared Traditional

K934191 - NEW BLUE MAX BALLOON DILATATION CATHETER

K934191 is an FDA 510(k) clearance for NEW BLUE MAX 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 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

FDA 510(k) Submission Details - K934191

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.

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 345
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K934191.
MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE
K934411 · Meadox Medicals, Div. Boston Scientific Corp. · Jan 1994
CORDIS OPTA 5(TM), MODIFICATION
K933236 · Cordis Corp. · Dec 1993
TYSHAK PERIPHERAL BALLOON DILATION CATHETER
K931009 · NuMED, Inc. · Dec 1993
VANTAGE DIALTAION CATHETER
K934433 · Peripheral Systems Group · Dec 1993
SCIMED MAVERICK PTA CATHETER
K932537 · Scimed Life Systems, Inc. · Dec 1993
ULTRA THIN BALLOON DILATATION CATHETER
K924320 · Boston Scientific Corp · Nov 1993