510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K843501Substantially Equivalent

Balloon Dilation Catheter

Advanced Cardiovascular Systems, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843501 is the FDA 510(k) clearance record for BALLOON DILATION CATHETER, a class II device, cleared for Advanced Cardiovascular Systems, Inc. on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list 103 510(k) clearances for Advanced Cardiovascular Systems, Inc., from to . As of , FDA records show no recalls naming K843501.

Clearance record

Decision date
Received
(28 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Advanced Cardiovascular Systems, Inc. 4221 Richmond Rd., NW, Walker MI
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