The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Vas-cath Flexxicon 2 Dual Lumen Dialysis Catheters.
| Device ID | K914162 |
| 510k Number | K914162 |
| Device Name: | VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS |
| Classification | Catheter, Subclavian |
| Applicant | VAS-CATH, INC. 2380 TEDIO ST. Mississauga,ontario, CA L5a3v3 |
| Contact | Marco A.guillen |
| Correspondent | Marco A.guillen VAS-CATH, INC. 2380 TEDIO ST. Mississauga,ontario, CA L5a3v3 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-17 |
| Decision Date | 1993-07-01 |