The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Advanta Super Soft Graft.
Device ID | K000504 |
510k Number | K000504 |
Device Name: | ADVANTA SUPER SOFT 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 | 2000-02-15 |
Decision Date | 2000-03-01 |