Company ยท US
Medtronic Bio-Medicus, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1998. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 6 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 |
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 1 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 1 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 1998 | K973237 | CSS-CARDIOPLEGIA SAFETY SYSTEM Medtronic Bio-Medicus, Inc. | DWB |
| Feb 25, 1998 | K973011 | BPX80 BIO-PUMP (BPX80) Medtronic Bio-Medicus, Inc. | KFM |
| Jan 16, 1996 | K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM Medtronic Bio-Medicus, Inc. | DTY |
| Feb 17, 1995 | K941922 | MEDSAT OXYGEN SATURATION SYSTEM Medtronic Bio-Medicus, Inc. | DRY |
| Dec 23, 1994 | K936091 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER Medtronic Bio-Medicus, Inc. | DWA |
| Jul 20, 1994 | K941921 | BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 Medtronic Bio-Medicus, Inc. | DWA |
| Jul 8, 1993 | K924208 | BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) Medtronic Bio-Medicus, Inc. | DPT |
| Jun 2, 1993 | K926357 | MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 Medtronic Bio-Medicus, Inc. | DWA |
| May 7, 1993 | K924206 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E Medtronic Bio-Medicus, Inc. | DWA |
| May 6, 1993 | K924205 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 Medtronic Bio-Medicus, Inc. | DWA |
| Mar 26, 1993 | K924642 | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER Medtronic Bio-Medicus, Inc. | DWF |
| Dec 8, 1992 | K924643 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT Medtronic Bio-Medicus, Inc. | DWF |
| May 20, 1992 | K914754 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D Medtronic Bio-Medicus, Inc. | DWA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||