The following data is part of a premarket notification filed by Vas-cath Of Canada Ltd. with the FDA for Vas-cath Parallel Dual Luman Jugular Cannual Cath.
Device ID | K844336 |
510k Number | K844336 |
Device Name: | VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH |
Classification | Catheter, Subclavian |
Applicant | VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
Contact | Kamal Kalwani |
Correspondent | Kamal Kalwani VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
Product Code | LFJ |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-08 |
Decision Date | 1985-03-13 |