The following data is part of a premarket notification filed by Catheter Technology Corp. with the FDA for Groshong Cv Catheter Repair Kit.
| Device ID | K871998 |
| 510k Number | K871998 |
| Device Name: | GROSHONG CV CATHETER REPAIR KIT |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | CATHETER TECHNOLOGY CORP. 3385 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols CATHETER TECHNOLOGY CORP. 3385 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-26 |
| Decision Date | 1987-06-24 |