The following data is part of a premarket notification filed by Vas-cath Of Canada Ltd. with the FDA for Vas-cath Permanent Single Lumen Hemodialysis Cath.
| Device ID | K871487 |
| 510k Number | K871487 |
| Device Name: | VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH |
| Classification | Catheter, Subclavian |
| Applicant | VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
| Contact | Katherine H Crewe |
| Correspondent | Katherine H Crewe VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-15 |
| Decision Date | 1987-06-12 |