510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961980Substantially Equivalent

Bipore Balloon Dilatation Catheter

Bipore, Inc., Northvale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961980 is the FDA 510(k) clearance record for BIPORE BALLOON DILATATION CATHETER, a class II device, cleared for Bipore, Inc. on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list 10 510(k) clearances for Bipore, Inc., from to . As of , FDA records show no recalls naming K961980.

Clearance record

Decision date
Received
(115 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Bipore, Inc. 31 Industrial Pkwy., Northvale NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LIT

Trailing 12 months
5 clearances under product code LIT in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LIT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20262
October 20260