The following data is part of a premarket notification filed by Vas-cath Of Canada Ltd. with the FDA for Luer Lock Connectors / Ridig P.v.c..
Device ID | K875188 |
510k Number | K875188 |
Device Name: | LUER LOCK CONNECTORS / RIDIG P.V.C. |
Classification | Catheter, Subclavian |
Applicant | VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
Contact | Katherine Crewe |
Correspondent | Katherine Crewe 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 | 1987-12-17 |
Decision Date | 1988-03-02 |