510(K) CLEARANCES 63 ▲12RECALLS POSTED 17 ▼8CLASS I 1PMA DECISIONS 48 ▼2WEEK ENDING / FDA DATA AS OF
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K991540Substantially Equivalent

Workhorse Percutaneous Transluminal Angioplasty Balloon Catheter

Boston Scientific Corporation, Queensburgy NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991540 is the FDA 510(k) clearance record for WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER, a class II device, cleared for AngioDynamics, Inc. on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K991540.

Clearance record

Decision date
Received
(149 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
AngioDynamics, Inc. 603 Queensbury Ave., Queensburgy NY
510(k) summary
Statement
Third party review
No

Clearances, product code LIT

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