MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT— 510(k) K960766

Name: FDA 510(k) clearance K960766
Creator: U.S. Food and Drug Administration
Published: 1997-03-19

Substantially Equivalent - Subject to Tracking Reg.

Meadox Medicals, Div. Boston Scientific Corp.

FDA 510(k) clearance K960766 for MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT, Substantially Equivalent - Subject to Tracking Reg. on 1997-03-19. Applicant: Meadox Medicals, Div. Boston Scientific Corp.. Device class: 2.

Clearance details

Applicant: Meadox Medicals, Div. Boston Scientific Corp.
Product code: Code DYF
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1996-02-26
Decision date: 1997-03-19
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Oakland, NJ, US

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