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510(k) K853313

Device
DUROMEDICS CARDIAC VALVE SIZER SET
Applicant
HEMEX SCIENTIFIC, INC.
510(k) number
K853313
Product code
DTI  
Decision
Substantially Equivalent (SESE)
Decision date
1985-11-01
Date received
1985-08-07
Regulation
870.3945
Classification name
Sizer, Heart-valve, Prosthesis
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN L ELY
Address
1300a E. Anderson Ln. Austin TX US 78752 78752

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DTI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952184CARBOMEDICS SUPRA-ANNULAR VALVE SIZERCarbomedics, Inc.1995-11-29
K934951VALVE SIZERCarbomedics, Inc.1993-12-10
K881279EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SETBaxter Healthcare Corp1988-05-18
K852612METRONIC MODEL F7700 HEART VALVE SIZERSMedtronic Vascular1985-09-23
K820887MITRAL VALVE ORIFICE SIZERCeltech1982-07-08
K801885HANCOCK * OBTURATORSHancock Laboratories, Inc.1980-09-09

Legacy Summary#

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FDA Review#

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