The following data is part of a premarket notification filed by Block Medical, Inc. with the FDA for C-series Homepump.
| Device ID | K944692 |
| 510k Number | K944692 |
| Device Name: | C-SERIES HOMEPUMP |
| Classification | Set, Administration, Intravascular |
| Applicant | BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
| Contact | Robert J Bard |
| Correspondent | Robert J Bard BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-23 |
| Decision Date | 1995-05-02 |