The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Advanta Sst Bifurcated Graft.
Device ID | K020767 |
510k Number | K020767 |
Device Name: | ADVANTA SST BIFURCATED GRAFT |
Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
Contact | Karen Hall |
Correspondent | Karen Hall ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
Product Code | DSY |
CFR Regulation Number | 870.3450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-08 |
Decision Date | 2002-04-03 |