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Data / Medical devices / Israel / ProCatid Medcial Ltd

ProCatid Medcial Ltd: FDA-registered device maker in Caesarea Northern, Israel, 2 510(k) clearances

ProCatid Medcial Ltd is registered with the FDA (registration 3012121095) in Caesarea Northern, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 21, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3012121095
Address
Ha-Eshel 2, Caesarea Northern, Israel, 3088900
Owner or operator
ProCatid Medical Ltd (10050446)
Roles
Manufacturer
First device listed
November 18, 2015
Registered through
2026
Brand names listed
D253542, D342547, D342548

Devices it lists

DeviceProduct codeClassRoleSource
Temporary Carotid Catheter For Embolic CaptureNTE2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 21, 2018K180023WIRIONNTESubstantially EquivalentGardia Medical , Ltd.accessdata.fda.gov
June 4, 2015K143570WIRIONNTESubstantially EquivalentGardia Medicalaccessdata.fda.gov

Compare with other makers

Updated March 21, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.