The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Meadox Exxcel Eptfe Vascular Graft.
Device ID | K962433 |
510k Number | K962433 |
Device Name: | MEADOX EXXCEL EPTFE VASCULAR GRAFT |
Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 15 THORNTON RD. Oakland, NJ 07436 |
Contact | Stephen B Anderson |
Correspondent | Stephen B Anderson MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 15 THORNTON RD. Oakland, NJ 07436 |
Product Code | DSY |
CFR Regulation Number | 870.3450 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-24 |
Decision Date | 1997-03-17 |
Summary: | summary |