The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Dcat Embolectomy Catheter System.
| Device ID | K971314 |
| 510k Number | K971314 |
| Device Name: | DCAT EMBOLECTOMY CATHETER SYSTEM |
| Classification | Catheter, Embolectomy |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-09 |
| Decision Date | 1998-03-17 |