The following data is part of a premarket notification filed by 3m Company with the FDA for Sarns Delphin Base Adapter With Battery.
| Device ID | K902198 |
| 510k Number | K902198 |
| Device Name: | SARNS DELPHIN BASE ADAPTER WITH BATTERY |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | 3M COMPANY 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Contact | Simpson, Md |
| Correspondent | Simpson, Md 3M COMPANY 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886799001714 | K902198 | 000 |
| 00886799000120 | K902198 | 000 |