The following data is part of a premarket notification filed by Arterial Vascular Engineering Massachusetts, Inc. with the FDA for Ave Gl-1 Guiding Catheter.
| Device ID | K984482 |
| 510k Number | K984482 |
| Device Name: | AVE GL-1 GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC. 129 CONCORD RD. P.O. BOX 566 Billerica, MA 01821 |
| Contact | Norma J Lemay |
| Correspondent | Norma J Lemay ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC. 129 CONCORD RD. P.O. BOX 566 Billerica, MA 01821 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-16 |
| Decision Date | 1999-07-30 |
| Summary: | summary |