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 |