The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Modification Hemofiltration Catheter Hf-100.
| Device ID | K890717 |
| 510k Number | K890717 |
| Device Name: | MODIFICATION HEMOFILTRATION CATHETER HF-100 |
| Classification | Catheter, Femoral |
| Applicant | VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Contact | Betty-ann Butcher |
| Correspondent | Betty-ann Butcher VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Product Code | LFK |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-13 |
| Decision Date | 1989-04-05 |