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
SUBSCRIBE / SIGN IN
K827847Substantially Equivalent

Argon Fiber Optic Catheter

Hgm, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827847 is the FDA 510(k) clearance record for ARGON FIBER OPTIC CATHETER, cleared for Hgm, Inc. on . FDA records list 21 510(k) clearances for Hgm, Inc., from to . As of , FDA records show no recalls naming K827847.

Clearance record

Decision date
Received
(60 days to decision)
Review panel
Unknown
Applicant
Hgm, Inc. 3959 W. 1820 S., Salt Lake City UT
Third party review
No