The following data is part of a premarket notification filed by Infucare Products, Inc. with the FDA for Vascular Access Port Continuous Infusion Set.
| Device ID | K891226 |
| 510k Number | K891226 |
| Device Name: | VASCULAR ACCESS PORT CONTINUOUS INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | INFUCARE PRODUCTS, INC. P.O. BOX 1543 Palm Harbor, FL 34682 |
| Contact | Joseph E Harms |
| Correspondent | Joseph E Harms INFUCARE PRODUCTS, INC. P.O. BOX 1543 Palm Harbor, FL 34682 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-07 |
| Decision Date | 1989-05-30 |