The following data is part of a premarket notification filed by Vas-cath Of Canada Ltd. with the FDA for Vas-cath Dsa Catheter/tray.
Device ID | K834232 |
510k Number | K834232 |
Device Name: | VAS-CATH DSA CATHETER/TRAY |
Classification | Catheter, Percutaneous |
Applicant | VAS-CATH OF CANADA LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-06 |
Decision Date | 1984-04-24 |