The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Vas-cath Ureteral Stents Catheter, Modification.
| Device ID | K905505 |
| 510k Number | K905505 |
| Device Name: | VAS-CATH URETERAL STENTS CATHETER, MODIFICATION |
| Classification | Stent, Ureteral |
| 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 | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-23 |
| Decision Date | 1991-04-09 |