Shiley, Inc. - FDA 510(k) Cleared Devices

Cleared Oct 19, 1984

SHILEY DISPOS. CANNULA FENESTRATED LOW

K843729 · BTO

Anesthesiology · 25d

Cleared Oct 19, 1984

SHILEY DISPOS. DECANNULATION PLUG W/SW/

K843730 · BTO

Anesthesiology · 25d

Cleared Oct 18, 1984

SHILEY CORONARY CARDIOPLEGIA ADAPTOR

K843542 · DWF

Cardiovascular · 41d

Cleared Oct 16, 1984

TETRAFLEX INTEGRALLY SUPPORTED PTFE

K831822 · DSY

Cardiovascular · 497d

Cleared Aug 17, 1984

SHILEY VENOUS RESERVOIR

K842337 · DTN

Cardiovascular · 73d

Cleared Aug 10, 1984

MULTIPRO CATHETER

K841797 · DQY

Cardiovascular · 109d

Cleared Aug 10, 1984

SHILEY CARDIOTOMY RESERVOIR W/FILTER

K842711 · DTN

Cardiovascular · 29d

Cleared Aug 03, 1984

ARTERIAL EMBOLECTOMY CATHETER

K840198 · DXE

Cardiovascular · 198d

Cleared Jul 26, 1984

SECHRIST AIR-OXYGEN MIXER & ANCILLARY

K841789 · BZR

Anesthesiology · 87d

Cleared Apr 25, 1984

SINGLE LUMEN SUBCLAVIAN CANNULA

K840197 · LFJ

Gastroenterology & Urology · 98d

Cleared Apr 19, 1984

ARTERIAL FILTER PURGE LINE W/CHECK VALV

K840603 · DTL

Cardiovascular · 69d

Cleared Apr 17, 1984

SHILEY PREBYPASS FILTER

K840450 · KRJ

Cardiovascular · 76d

Cleared Apr 12, 1984

3-DAY BIOINDICATOR RELEASE PROCESS FOR

K833830 · DWF

Cardiovascular · 157d

Cleared Mar 27, 1984

SHILEY DISPOS. TEMP. PROBES

K833981 · FLL

General Hospital · 131d

Cleared Mar 21, 1984

3-DAY BIOINDICATOR RELEASE FOR STERIL

K833831 · BTR

Anesthesiology · 135d

Cleared Mar 15, 1984

3-DAY BIOINDICATOR RELEASE FOR RESPIR

K833832 · BTO

Anesthesiology · 129d

Cleared Mar 09, 1984

DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY

K840539 · BTO

Anesthesiology · 30d

Cleared Feb 04, 1984

LAL TEST RELEASE & BONCHEK CAR/JACKET

K833555 · DTR

Cardiovascular · 110d

Cleared Dec 08, 1983

DUAL LUMEN SUBCLAVIAN CANNULA

K833848 · LFJ

Gastroenterology & Urology · 34d

Cleared Dec 01, 1983

SHILEY M2000 MEMBRANE OXYGENATOR

K833253 · DTZ

Cardiovascular · 72d

Cleared Oct 31, 1983

VENOUS RESERVOIR

K832924 · DTN

Cardiovascular · 63d

Cleared Oct 20, 1983

BLOOD OXYGENATOR 5070

K831894 · DTZ

Cardiovascular · 128d

Cleared Oct 19, 1983

IONESCU-SHILEY LOW POROSITY COMPOSITE

K831865 · DSY

Cardiovascular · 131d

Cleared Oct 19, 1983

IONESCU-SHILEY LOW POROSITY AORTIC GRAFT

K831880 · DSY

Cardiovascular · 128d

Cleared Oct 19, 1983

BLOOD OXYGENATOR 50 70/S

K831895 · DTZ

Cardiovascular · 127d