JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
FDA 510(k) clearance K943803 · decided 1996-01-30
Clearance details
- K-number
- K943803
- Device name
- JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
- Applicant
- Janus Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-04
- Decision date
- 1996-01-30
- Days to decision
- 544 days
- Clearance type
- Traditional
- Product code
- DTQ
- Device class
- 2
- Regulation number
- 870.4220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Maquet HL Console for Heart Lung Machine HL20 HL 20 4-pumps console base: P/N 917741 HL 20 recall (Z-3084-2011) | Maquet Inc. | 2011-08-29 |
| Maquet HL Console for Heart Lung Machine HL20: HL 20 4-pumps console base: P/N 917741 HL 2 recall (Z-3057-2011) | Maquet Inc. | 2011-08-22 |
| Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20. recall (Z-1394-2011) | Maquet Cardiovascular Us Sales, Llc | 2011-02-22 |
| Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank recall (Z-0158-2007) | MAQUET Inc. | 2006-11-07 |
| Jostra HL-20 Heart Lung Machine - guiding pins recall (Z-0159-2007) | MAQUET Inc. | 2006-11-07 |