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
K832279Substantially Equivalent

Peripheral Transluminal Argioplasty

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

K832279 is the FDA 510(k) clearance record for PERIPHERAL TRANSLUMINAL ARGIOPLASTY, cleared for Sontek Corp. on . FDA records list 3 510(k) clearances for Sontek Corp., from to . As of , FDA records show no recalls naming K832279.

Clearance record

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