510(k) K011589

Device: 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
Applicant: BYPASS LTD.
510(k) number: K011589
Product code: NCA
Decision: Substantially Equivalent (SESE)
Decision date: 2001-12-26
Date received: 2001-05-23
Regulation: 878.4300
Classification name: Clip, Implantable, For Coronary Artery Bypass Graft (cabg)
Medical specialty: General & Plastic Surgery
Review panel: General & Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JONATHAN S KAHAN
Address: 555 Thirteenth St. NW Washington DC US 20004 20004

Source Documents#

Other 510(k) Records For Product Code NCA #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K013664	COALESCENT SURGICAL U-CLIP	Coalescent Surgical	2002-01-24
K003446	SYMMETRY AORTIC CLIP SYSTEM	St. Jude Medical Cardiovascular Group, Inc.	2001-05-21

Legacy Summary#

summary

FDA Review#

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