The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Modified Vas-cath Catheter Repair Kit.
Device ID | K890099 |
510k Number | K890099 |
Device Name: | MODIFIED VAS-CATH CATHETER REPAIR KIT |
Classification | Catheter, Subclavian |
Applicant | VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
Contact | Betty-anne Butcher |
Correspondent | Betty-anne Butcher VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario, CA L5a 3v3 |
Product Code | LFJ |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-10 |
Decision Date | 1989-04-11 |