The following data is part of a premarket notification filed by Haemotronic, Inc. with the FDA for Cavh/cvvh/cavhd Set Model #ht-hf/505.
| Device ID | K921597 |
| 510k Number | K921597 |
| Device Name: | CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | HAEMOTRONIC, INC. 45 KULICK RD. Fairfield, NJ 07004 |
| Contact | Willer Ghelfi |
| Correspondent | Willer Ghelfi HAEMOTRONIC, INC. 45 KULICK RD. Fairfield, NJ 07004 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-03 |
| Decision Date | 1995-02-24 |