Cleared Traditional

K952063 - XXL BALLON DILATATION CATHETER

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

K952063 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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