The following data is part of a premarket notification filed by Vas-cath Of Canada Ltd. with the FDA for Vaccess Femoral Cannula.
Device ID | K842864 |
510k Number | K842864 |
Device Name: | VACCESS FEMORAL CANNULA |
Classification | Accessories, A-v Shunt |
Applicant | VAS-CATH OF CANADA LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNZ |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-23 |
Decision Date | 1984-08-08 |