The following data is part of a premarket notification filed by Vas-cath Of Canada Ltd. with the FDA for Uldall Subclavian Cannula Sc-100.
| Device ID | K791308 |
| 510k Number | K791308 |
| Device Name: | ULDALL SUBCLAVIAN CANNULA SC-100 |
| Classification | Cannula, A-v Shunt |
| Applicant | VAS-CATH OF CANADA LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIQ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-16 |
| Decision Date | 1979-08-03 |