Shiley, Inc. - FDA 510(k) Cleared Devices
174
Total
174
Cleared
0
Denied
120 devices
Cleared
Aug 10, 1984
SHILEY CARDIOTOMY RESERVOIR W/FILTER
Cardiovascular
29d
Cleared
Aug 03, 1984
ARTERIAL EMBOLECTOMY CATHETER
Cardiovascular
198d
Cleared
Apr 19, 1984
ARTERIAL FILTER PURGE LINE W/CHECK VALV
Cardiovascular
69d
Cleared
Apr 17, 1984
SHILEY PREBYPASS FILTER
Cardiovascular
76d
Cleared
Apr 12, 1984
3-DAY BIOINDICATOR RELEASE PROCESS FOR
Cardiovascular
157d
Cleared
Feb 04, 1984
LAL TEST RELEASE & BONCHEK CAR/JACKET
Cardiovascular
110d
Cleared
Dec 01, 1983
SHILEY M2000 MEMBRANE OXYGENATOR
Cardiovascular
72d
Cleared
Oct 31, 1983
VENOUS RESERVOIR
Cardiovascular
63d
Cleared
Oct 20, 1983
BLOOD OXYGENATOR 5070
Cardiovascular
128d
Cleared
Oct 19, 1983
IONESCU-SHILEY LOW POROSITY COMPOSITE
Cardiovascular
131d
Cleared
Oct 19, 1983
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
Cardiovascular
128d
Cleared
Oct 19, 1983
BLOOD OXYGENATOR 50 70/S
Cardiovascular
127d
Cleared
Sep 29, 1983
SHILEY MULTIPRO CATHETER
Cardiovascular
97d
Cleared
Sep 29, 1983
SHILEY GAS FILTER
Cardiovascular
49d
Cleared
Sep 20, 1983
SHILEY 3L CARDF PLUS
Cardiovascular
33d
Cleared
Mar 10, 1983
PATCH
Cardiovascular
122d
Cleared
Jan 05, 1983
CARDF
Cardiovascular
26d
Cleared
Dec 30, 1982
JACKET & SET
Cardiovascular
31d
Cleared
Jun 16, 1982
PUIG MASSANA-SHILEY ANNULOPLASTY RING
Cardiovascular
44d
Cleared
Dec 10, 1981
IONESCU-SHILEY VALVE HOLDER & HANDLE
Cardiovascular
17d
Cleared
Nov 02, 1981
SHILEY ARTERIAL FILTER W/40 MICRON SCREE
Cardiovascular
34d
Cleared
Jun 09, 1981
SHILEY ARTERIAL FILTER
Cardiovascular
25d
Cleared
May 21, 1981
BRONCHEK-SHILEY CARDIAC JACKET & BSC J
Cardiovascular
20d
Cleared
Apr 17, 1981
SHILEY S-100A (ADULT) BLOOD OXYGENATOR
Cardiovascular
53d
Cleared
Apr 03, 1981
SHILEY OXYGENATOR THERMISTOR PROBE
Cardiovascular
23d
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