510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K834433Substantially Equivalent

Ptca Balloon Catheters & Access.

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

K834433 is the FDA 510(k) clearance record for PTCA BALLOON CATHETERS & ACCESS., cleared for Advanced Cardiovascular Systems, Inc. on . FDA records list 103 510(k) clearances for Advanced Cardiovascular Systems, Inc., from to . As of , FDA records show no recalls naming K834433.

Clearance record

Decision date
Received
(139 days to decision)
Review panel
Unknown
Applicant
Advanced Cardiovascular Systems, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No