The following data is part of a premarket notification filed by Catheter Technology Corp. with the FDA for Cath-tech Port Implantable Vascular Access System.
| Device ID | K880571 |
| 510k Number | K880571 |
| Device Name: | CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | CATHETER TECHNOLOGY CORP. 3385 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Jack Speer |
| Correspondent | Jack Speer CATHETER TECHNOLOGY CORP. 3385 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-10 |
| Decision Date | 1988-03-04 |