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
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K803093Substantially Equivalent

Slit Catheter System

Howmedica Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803093 is the FDA 510(k) clearance record for SLIT CATHETER SYSTEM, cleared for Howmedica Corp. on . FDA records list 409 510(k) clearances for Howmedica Corp., from to . As of , FDA records show no recalls naming K803093.

Clearance record

Decision date
Received
(31 days to decision)
Review panel
Unknown
Applicant
Howmedica Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No