Cleared Traditional

K963000 - MAXI LD PTA BALLOON CATHETER

K963000 is an FDA 510(k) clearance for MAXI LD PTA BALLOON CATHETER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K963000 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
202d
Days
Class 2
Risk

K963000 is an FDA 510(k) clearance for the MAXI LD PTA BALLOON CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on February 20, 1997 after a review of 202 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 Cordis Corp. devices

FDA 510(k) Submission Details - K963000

510(k) Number K963000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1996
Decision Date February 20, 1997
Days to Decision 202 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
77d slower than avg
Panel avg: 125d · This submission: 202d
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 264
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K963000.
CHANNEL BALLOON CATHETER
K970379 · Boston Scientific Corp · May 1997
VANTAGE PERIPHERAL DILATATION CATHETER
K965183 · Guidant Corp. · Apr 1997
JUPITER PTA CATHETERS (VARIOUS)
K970299 · Cordis Corp. · Apr 1997
CORDIS OPTA PTA BALLOON CATHETER
K962945 · Cordis Corp. · Oct 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K960501 · Boston Scientific Corp · Apr 1996
BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER
K960517 · C.R. Bard, Inc. · Apr 1996