The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Vas-cath Flexxicon Dual Lumen Dialysis Catheter.
| Device ID | K881743 |
| 510k Number | K881743 |
| Device Name: | VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER |
| Classification | Catheter, Subclavian |
| Applicant | VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Contact | H Crewe |
| Correspondent | H Crewe VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-22 |
| Decision Date | 1988-06-23 |