The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angioptic Angiographic Catheter.
| Device ID | K954423 |
| 510k Number | K954423 |
| Device Name: | ANGIOPTIC ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ANGIODYNAMICS, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Contact | Jeffrey R Mannion |
| Correspondent | Jeffrey R Mannion ANGIODYNAMICS, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-21 |
| Decision Date | 1995-12-01 |