The following data is part of a premarket notification filed by Catheter Innovations, Inc. with the FDA for Catheter Innovations Implantable Port.
| Device ID | K993860 |
| 510k Number | K993860 |
| Device Name: | CATHETER INNOVATIONS IMPLANTABLE PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | CATHETER INNOVATIONS, INC. 3598 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Roger L Richins |
| Correspondent | Roger L Richins CATHETER INNOVATIONS, INC. 3598 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-15 |
| Decision Date | 1999-12-03 |
| Summary: | summary |