The following data is part of a premarket notification filed by Cordis Corp. with the FDA for 6f Hydrolyser Thrombectomy Catheter.
| Device ID | K990771 |
| 510k Number | K990771 |
| Device Name: | 6F 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-09 |
| Decision Date | 1999-06-25 |
| Summary: | summary |