CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M— 510(k) K011589

Substantially Equivalent

Bypass , Ltd.

FDA 510(k) clearance K011589 for CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M, Substantially Equivalent on 2001-12-26. Applicant: Bypass , Ltd.. Device class: 2.

Clearance details

Applicant
Bypass , Ltd.
Product code
Code NCA
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Washington, DC, US
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