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510(k) K200060

Device
Reprocessed NRG Transseptal Needle
Applicant
Innovative Health, LLC.
510(k) number
K200060
Product code
QLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-30
Date received
2020-01-13
Regulation
870.5175
Classification name
Septostomy Catheter, Reprocessed
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rick Ferreira
Address
1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QLZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213584Reprocessed NRG Transseptal NeedleInnovative Health, LLC2023-04-04

Legacy Summary#

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FDA Review#

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