510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K861453Substantially Equivalent

Stagnone Swivel-Joint Needle

Radtech, Inc., Albuquerque NM / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861453 is the FDA 510(k) clearance record for STAGNONE SWIVEL-JOINT NEEDLE, cleared for Radtech, Inc. on . FDA records list 2 510(k) clearances for Radtech, Inc., from to . As of , FDA records show no recalls naming K861453.

Clearance record

Decision date
Received
(18 days to decision)
Review panel
Unknown
Applicant
Radtech, Inc. 2610 San Mateo, NE Suite D, Albuquerque NM
Third party review
No