The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Minimax (tm) Hardshell Venous Res W/inte Card Filt.
| Device ID | K911789 |
| 510k Number | K911789 |
| Device Name: | MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT |
| Classification | Defoamer, 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 | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-22 |
| Decision Date | 1991-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994269786 | K911789 | 000 |