The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Continuous Arteriovenous Hemofiltration Cath. Kits.
| Device ID | K915215 |
| 510k Number | K915215 |
| Device Name: | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS |
| Classification | Catheter, Femoral |
| Applicant | AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
| Contact | B Kapany |
| Correspondent | B Kapany AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
| Product Code | LFK |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-18 |
| Decision Date | 1992-03-27 |