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510(k) K954848

Device
HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
Applicant
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
510(k) number
K954848
Product code
MAL  
Decision
Se Subject To Tracking Reg (ST)
Decision date
1996-02-01
Date received
1995-10-23
Regulation
870.3450
Classification name
Graft, Vascular, Synthetic/biologic Composite
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CAROLYN TAUBER
Address
112 Bauer Dr. Oakland NJ US 07436 07436

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MAL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K122612HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXXMaquet Cardiovascular, LLC2012-09-10
K103080ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.2011-01-19
K093231ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.2010-01-14
K052302HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATIONBoston Scientific Corp2005-09-12
K021213MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTSBoston Scientific Corp2002-04-19

Legacy Summary#

summary

FDA Review#

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