Cleared Traditional

K952063 - XXL BALLON DILATATION CATHETER

K952063 is an FDA 510(k) clearance for XXL BALLON 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 196-day FDA review.

K952063 · Boston Scientific Corp · Cardiovascular device
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Nov 1995
Decision
196d
Days
Class 2
Risk

K952063 is an FDA 510(k) clearance for the XXL BALLON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 196 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

FDA 510(k) Submission Details - K952063

510(k) Number K952063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1995
Decision Date November 14, 1995
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
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 K952063.
MS CLASSIQUE BALLOON DIATATION CATHETER
K953298 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 1996
COURIER BALLOON DILATATION CATHETER
K953569 · Boston Scientific Corp · Dec 1995
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
K953608 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1995
SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER
K953602 · Boston Scientific Corp · Oct 1995
BRAUN PTA BALLOON CATHETER
K951248 · B.Braun Medical, Inc. · Jun 1995
OPTA 5(TM) 5F PTA BALLOON CATHETER
K950119 · Cordis Corp. · May 1995