The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Mvr Collapsible Venous Reservoir Bag.
| Device ID | K920774 |
| 510k Number | K920774 |
| Device Name: | MVR COLLAPSIBLE VENOUS RESERVOIR BAG |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Norma L Lowe |
| Correspondent | Norma L Lowe MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-20 |
| Decision Date | 1992-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994931027 | K920774 | 000 |
| 20613994931010 | K920774 | 000 |
| 20613994931003 | K920774 | 000 |
| 20613994930990 | K920774 | 000 |
| 20643169767595 | K920774 | 000 |
| 20643169767571 | K920774 | 000 |
| 20643169767557 | K920774 | 000 |
| 20643169767533 | K920774 | 000 |