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510(k) K014124

Device
NUMED COEFFICIENT PTV CATHETERS
Applicant
NUMED, INC.
510(k) number
K014124
Product code
OMZ  
Decision
Substantially Equivalent (SESE)
Decision date
2002-01-16
Date received
2001-12-17
Regulation
870.1250
Classification name
Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
NICHELLE R LAFLASH
Address
2880 Main St. Hopkinton NY US 12965 12965

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OMZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153069Edwards Balloon CatheterEdwards Lifesciences2016-01-07
K131002VIDA PTV DILATATON CATHETERC.R. Bard, Inc.2013-07-02
K122367BARD PTV DILATATION CATHETERC.R. Bard, Inc.2012-11-02
K102473MULLINS-X PTV CATHETERNuMED, Inc.2010-12-09

Legacy Summary#

summary

FDA Review#

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