510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K843586Substantially Equivalent

Thora-Klex Autotransfusion Kit

C.R. Bard Inc, Murray Hill NJ / Traditional, Substantially Equivalent

K843586 is the FDA 510(k) clearance record for THORA-KLEX AUTOTRANSFUSION KIT, cleared for C.R. Bard, Inc. on . FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K843586.

Clearance record

Decision date
Received
(44 days to decision)
Review panel
Unknown
Applicant
C.R. Bard, Inc. 731 Central Ave., Murray Hill NJ
Third party review
No