510(k) K003446

Device: SYMMETRY AORTIC CLIP SYSTEM
Applicant: ST. JUDE MEDICAL CARDIOVASCULAR GROUP, INC.
510(k) number: K003446
Product code: NCA
Decision: Substantially Equivalent (SESE)
Decision date: 2001-05-21
Date received: 2000-11-06
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: ROBERT L SHERIDAN
Address: 12300 Twinbrook Pkwy., Suite 625 Rockville MD US 20852 20852

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
K011589	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	Bypass , Ltd.	2001-12-26

Legacy Summary#

summary

FDA Review#

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