The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Powerflex Plus Pta Balloon Catheter.
Device ID | K971516 |
510k Number | K971516 |
Device Name: | CORDIS POWERFLEX PLUS PTA BALLOON CATHETER |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Mirjam Barboza |
Correspondent | Mirjam Barboza CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | LIT |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-28 |
Decision Date | 1997-07-23 |
Summary: | summary |