The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics Soft-vu Hydrophilic Coated Angiographic Catheter.
| Device ID | K001578 |
| 510k Number | K001578 |
| Device Name: | ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-22 |
| Decision Date | 2000-10-13 |