The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Tempo Aqua Angiographic Catheter.
Device ID | K000579 |
510k Number | K000579 |
Device Name: | TEMPO AQUA ANGIOGRAPHIC CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
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 | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-22 |
Decision Date | 2000-05-03 |