Medical Device Manufacturer · US , Eden Prairie , MN

Medtronic Bio-Medicus, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1992

Recent clearances: CSS-CARDIOPLEGIA SAFETY SYSTEM, BPX80 BIO-PUMP (BPX80), BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medtronic Bio-Medicus, Inc. Cardiovascular ✕

13 devices

1-13 of 13

Cleared Apr 27, 1998

CSS-CARDIOPLEGIA SAFETY SYSTEM

Cardiovascular · 242d

Cleared Feb 25, 1998

BPX80 BIO-PUMP (BPX80)

Cardiovascular · 196d

Cleared Jan 16, 1996

BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM

Cardiovascular · 110d

Cleared Feb 17, 1995

MEDSAT OXYGEN SATURATION SYSTEM

Cardiovascular · 303d

Cleared Dec 23, 1994

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER

Cardiovascular · 366d

Cleared Jul 20, 1994

BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550

Cardiovascular · 91d

Cleared Jul 08, 1993

BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)

Cardiovascular · 322d

Cleared Jun 02, 1993

MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150

Cardiovascular · 163d

Cleared May 07, 1993

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E

Cardiovascular · 260d

Cleared May 06, 1993

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550

Cardiovascular · 259d

Cleared Mar 26, 1993

MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER

Cardiovascular · 193d

Cleared Dec 08, 1992

MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT

Cardiovascular · 85d

Cleared May 20, 1992

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D

Cardiovascular · 211d