The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for Silicone Bi-lumen Irrigation Embolectomy Cath..
Device ID | K893680 |
510k Number | K893680 |
Device Name: | SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. |
Classification | Catheter, Embolectomy |
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 | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-16 |
Decision Date | 1989-08-01 |