The following data is part of a premarket notification filed by Arterial Vascular Engineering, Inc. with the FDA for Ave 4f Siteseer Cardiovascular Angiographic Catheter.
| Device ID | K984627 |
| 510k Number | K984627 |
| Device Name: | AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ARTERIAL VASCULAR ENGINEERING, INC. 129 CONCORD RD. Billerica, MA 01821 |
| Contact | Deborah L Herrington |
| Correspondent | Deborah L Herrington ARTERIAL VASCULAR ENGINEERING, INC. 129 CONCORD RD. Billerica, MA 01821 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-30 |
| Decision Date | 1999-07-27 |
| Summary: | summary |