Cleared Traditional

K961980 - BIPORE BALLOON DILATATION CATHETER

K961980 is an FDA 510(k) clearance for BIPORE BALLOON DILATATION CATHETER, manufactured by Bipore, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K961980

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
Combination Product No
PCCP Authorized No
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.

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 353
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K961980.
FOCUS PV BALLOON DILATATION CATHETER
K963688 · Cardiovascular Dynamics, Inc. · Mar 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