Medtronic Bio-Medicus, Inc.
Eden Prairie, MN, US
Medtronic Bio-Medicus, Inc. appears in FDA device records in Eden Prairie, MN. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Medtronic Bio-Medicus, Inc. between 1992 and 1998. The busiest year on record is 1993, with 5. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 5 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973237 | CSS-CARDIOPLEGIA SAFETY SYSTEM | DWB | Substantially Equivalent | |
| K973011 | BPX80 BIO-PUMP (BPX80) | KFM | Substantially Equivalent | |
| K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | DTY | Substantially Equivalent | |
| K941922 | MEDSAT OXYGEN SATURATION SYSTEM | DRY | Substantially Equivalent | |
| K936091 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER | DWA | Substantially Equivalent | |
| K941921 | BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 | DWA | Substantially Equivalent | |
| K924208 | BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) | DPT | Substantially Equivalent | |
| K926357 | MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 | DWA | Substantially Equivalent | |
| K924206 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E | DWA | Substantially Equivalent | |
| K924205 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 | DWA | Substantially Equivalent | |
| K924642 | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER | DWF | Substantially Equivalent | |
| K924643 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT | DWF | Substantially Equivalent | |
| K914754 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D | DWA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- DPTProbe, Blood-Flow, Extravascular
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain