The following data is part of a premarket notification filed by International Biophysics Corporation with the FDA for Flopump 57ml Centrifugal Pump.
| Device ID | K193663 |
| 510k Number | K193663 |
| Device Name: | FloPump 57mL Centrifugal Pump |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | International Biophysics Corporation 2101 E. St. Elmo Road Austin, TX 78744 |
| Contact | Geoff Marcek |
| Correspondent | Geoff Marcek International Biophysics Corporation 2101 E. St. Elmo Road Austin, TX 78744 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-31 |
| Decision Date | 2021-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814321020445 | K193663 | 000 |
| 00814321020438 | K193663 | 000 |