I Tek Medical Technologies

FDA Filings

This page includes the latest FDA filings for I Tek Medical Technologies. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008627763
• FEI Number: 3008627763
• Name: I-Tek Medical Technologies, LLC
• Owner & Operator: I-Tek Medical Technologies
• Contact Address: 1837 Buerkle Road ; White Bear Lake MN 55110 US
• Official Correspondent:
  • Patrick Haley
  • 1-651-2368848-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1837 Buerkle Rd ; White Bear Lake, MN 55110 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
IWW I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	Elution Test Vial Bottle use with CardioGen-82 Infusion Syst; Elution Test Vial Shield use with CardioGen-82 Infusion S	2017-03-14
HPP I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	PLT-165A; XLT-105F; XLT-125A; XLT-225A; XLT-85F; XLT-ENT	2017-03-14
PMN K140804 | DXX I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	VDRIVE WITH V-LOOP	2014-10-10
PMN K140804 | DQX I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	VDRIVE WITH V-LOOP	2014-10-10
PMN K131955 | HAW I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	NEUROBLATE SYSTEM	2014-10-10
PMN K131955 | GEX I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	NEUROBLATE SYSTEM	2014-10-10
PMN K122659 | DXX I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	VDRIVE W/V-SONO	2014-10-10
PMN K122659 | DQX I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	VDRIVE W/V-SONO	2014-10-10
PMN K120381 | MJN I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	q50 plus stent graft balloon catheter18	2014-10-10
PMN K120381 | DQY I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	q50 plus stent graft balloon catheter18	2014-10-10
PMN K071029 | DQX I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)	2014-10-10
FDG I-Tek Medical Technologies, LLC [I-Tek Medical Technologies]	I-Tek Fiber Optic Illuminator	2014-10-10