The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for Silicone Flow-directed Thermodilution Catheter.
Device ID | K893435 |
510k Number | K893435 |
Device Name: | SILICONE FLOW-DIRECTED THERMODILUTION CATHETER |
Classification | Catheter, Flow Directed |
Applicant | CATHLAB CORP. 2695 DOW AVE. Tustin, CA 92680 |
Contact | Daniel R Lucas |
Correspondent | Daniel R Lucas CATHLAB CORP. 2695 DOW AVE. Tustin, CA 92680 |
Product Code | DYG |
CFR Regulation Number | 870.1240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-02 |
Decision Date | 1989-09-26 |