The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Vas-cath Ureteral Stent Catheter.
| Device ID | K894357 |
| 510k Number | K894357 |
| Device Name: | VAS-CATH URETERAL STENT CATHETER |
| Classification | Stent, Ureteral |
| Applicant | VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
| Contact | Katherine H Crewe |
| Correspondent | Katherine H Crewe 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 | 1989-07-14 |
| Decision Date | 1989-10-03 |