The following data is part of a premarket notification filed by Vas-cath Of Canada Ltd. with the FDA for Vas-cath Pericardiocentesis Catheter, Set & Tray.
Device ID | K863982 |
510k Number | K863982 |
Device Name: | VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY |
Classification | Catheter, Infusion |
Applicant | VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
Contact | Katherine H Crewe |
Correspondent | Katherine H Crewe VAS-CATH OF CANADA LTD. 2380 TEDLO ST. MISSISSAUGA Ontario, L5a 3v3, CA |
Product Code | JCY |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-14 |
Decision Date | 1986-10-24 |