The following data is part of a premarket notification filed by International Biophysics Corporation with the FDA for Flopump 32ml, Sterile, Flopump 32ml, Non-sterile.
| Device ID | K170029 |
| 510k Number | K170029 |
| Device Name: | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile |
| 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 | 2017-01-04 |
| Decision Date | 2017-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814321020148 | K170029 | 000 |
| 00814321020131 | K170029 | 000 |