The following data is part of a premarket notification filed by Vas-cath Of Canada Ltd. with the FDA for Double Lumen Subclavin Catheter Sc-400.
| Device ID | K810745 |
| 510k Number | K810745 |
| Device Name: | DOUBLE LUMEN SUBCLAVIN CATHETER SC-400 |
| Classification | Catheter, Subclavian |
| Applicant | VAS-CATH OF CANADA LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-19 |
| Decision Date | 1981-03-31 |