510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K810689Substantially Equivalent

Balloon Catheter

Surgimed Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810689 is the FDA 510(k) clearance record for BALLOON CATHETER, cleared for Surgimed Corp. on . FDA records list 6 510(k) clearances for Surgimed Corp., from to . As of , FDA records show no recalls naming K810689.

Clearance record

Decision date
Received
(137 days to decision)
Review panel
Unknown
Applicant
Surgimed Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No