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 |