MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
FDA 510(k) clearance K900640 · decided 1990-04-20
Clearance details
- K-number
- K900640
- Device name
- MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1990-02-09
- Decision date
- 1990-04-20
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- DTR
- Device class
- 2
- Regulation number
- 870.4240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbe recall (Z-0156-2015) | Terumo Cardiovascular Systems Corp | 2014-10-31 |
| Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ recall (Z-2615-2010) | Terumo Cardiovascular Corporation | 2010-09-29 |
| Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N 6 recall (Z-2150-2010) | Terumo Cardiovascular Systems Corp | 2010-08-02 |
| Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 7 recall (Z-2163-2010) | Terumo Cardiovascular Systems Corp | 2010-08-02 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |