The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Tidalport-ap Implantable Apheresis Vascular Access Port.
| Device ID | K192291 |
| 510k Number | K192291 |
| Device Name: | TidalPort-AP Implantable Apheresis Vascular Access Port |
| Classification | Subcutaneous Implanted Apheresis Port |
| Applicant | Norfolk Medical Products, Inc. 7350 N. Ridgeway Avenue Skokie, IL 60076 |
| Contact | Natan Pheil |
| Correspondent | Natan Pheil Norfolk Medical Products, Inc. 7350 N. Ridgeway Avenue Skokie, IL 60076 |
| Product Code | PTD |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-23 |
| Decision Date | 2020-08-20 |