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510(k) K161451

Device
BIB Stent Placement Catheter
Applicant
NUMED, INC.
510(k) number
K161451
Product code
NVM  
Decision
Substantially Equivalent (SESE)
Decision date
2016-09-22
Date received
2016-05-26
Regulation
870.1250
Classification name
Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Nichelle LaFlesh
Address
2880 Main St. Hopkinton NY US 12965 12965

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NVM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213915BIB Stent Placement CatheterNuMED, Inc.2022-01-12
K211134BIB Stent Placement CatheterNuMED, Inc.2021-05-27
K160889BIB Stent Placement CatheterNuMED, Inc.2016-05-20
K050857BIB PTA BALLOON CATHETERNuMED, Inc.2005-07-28

Legacy Summary#

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FDA Review#

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