The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Vas-cath Dualator(tm) Vessel Dilator.
| Device ID | K914210 |
| 510k Number | K914210 |
| Device Name: | VAS-CATH DUALATOR(TM) VESSEL DILATOR |
| Classification | Dilator, Vessel |
| Applicant | VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Contact | Marco A Guillen |
| Correspondent | Marco A Guillen VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Product Code | FKA |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-19 |
| Decision Date | 1993-07-01 |