The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Vascular-access Port Change Catheter.
| Device ID | K841150 |
| 510k Number | K841150 |
| Device Name: | VASCULAR-ACCESS PORT CHANGE CATHETER |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | NORFOLK MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-08 |
| Decision Date | 1984-04-24 |