The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Modification To 7f Hydrolyser Thrombectomy Catheter.
Device ID | K990805 |
510k Number | K990805 |
Device Name: | MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER |
Classification | Catheter, Embolectomy |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Ariel Mactavish |
Correspondent | Ariel Mactavish CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-11 |
Decision Date | 1999-03-15 |
Summary: | summary |