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510(k) K934951

Device
VALVE SIZER
Applicant
CARBOMEDICS, INC.
510(k) number
K934951
Product code
DTI  
Decision
Substantially Equivalent (SESE)
Decision date
1993-12-10
Date received
1993-10-18
Regulation
870.3945
Classification name
Sizer, Heart-valve, Prosthesis
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOY FISHER
Address
1300-A E. Anderson Ln. Austin TX US 78752 78752

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K881279EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SETBaxter Healthcare Corp1988-05-18
K853313DUROMEDICS CARDIAC VALVE SIZER SETHemex Scientific, Inc.1985-11-01
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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