The following data is part of a premarket notification filed by Catheter Technology Corp. with the FDA for Cath-tech Polyurethane Umbilical Vess.
| Device ID | K842577 |
| 510k Number | K842577 |
| Device Name: | CATH-TECH POLYURETHANE UMBILICAL VESS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | CATHETER TECHNOLOGY CORP. 3378 SOUTH 275 EAST Salt Lake City, UT 84115 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols CATHETER TECHNOLOGY CORP. 3378 SOUTH 275 EAST Salt Lake City, UT 84115 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-03 |
| Decision Date | 1985-03-13 |