Cleared Traditional

K961980 - BIPORE BALLOON DILATATION CATHETER

K961980 is the FDA 510(k) clearance for BIPORE BALLOON DILATATION CATHETER by Bipore, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K961980 · Bipore, Inc. · Cardiovascular device
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Sep 1996
Decision
115d
Days
Class 2
Risk

K961980 is an FDA 510(k) clearance for the BIPORE BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Bipore, Inc. (Northvale, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 115 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 Bipore, Inc. devices

Submission Details

510(k) Number K961980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1996
Decision Date September 12, 1996
Days to Decision 115 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 125d · This submission: 115d
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 244
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K961980.
JUPITER PTA CATHETERS (VARIOUS)
K970299 · Cordis Corp. · Apr 1997
MAXI LD PTA BALLOON CATHETER
K963000 · Cordis Corp. · Feb 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
MEGA PTA BALLOON CATHETER
K955886 · Cordis Corp. · Mar 1996