The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Advanta Graft.
Device ID | K992441 |
510k Number | K992441 |
Device Name: | ADVANTA GRAFT |
Classification | Prosthesis, Vascular Graft, Of Less Then 6mm 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 | DYF |
CFR Regulation Number | 870.3450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-22 |
Decision Date | 1999-08-20 |