The following data is part of a premarket notification filed by Arterial Vascular Engineering, Inc. with the FDA for Gt1 Floppy, Gt1 Hi-per Flex, Gt1 Light Support.
| Device ID | K983927 |
| 510k Number | K983927 |
| Device Name: | GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT |
| Classification | Occluder, Catheter Tip |
| 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 | DQT |
| CFR Regulation Number | 870.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-05 |
| Decision Date | 1999-03-11 |
| Summary: | summary |