Cardiotek B V

FDA Filings

This page includes the latest FDA filings for Cardiotek B V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008329188
• FEI Number: 3008329188
• Name: CARDIOTEK BV
• Owner & Operator: Schwarzer Cardiotek GmbH
• Contact Address: Im Zukunftspark 3 ; Heilbronn DE-NOTA 74076 DE
• Official Correspondent:
  • Tatjana Nuber
  • 49-7131-2774-500
• US Agent:
  • Melissa Walker
  • Graematter, Inc.
  • 636 4057498
  • 702 9208509
  • mwalker@graematter.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Dr. Nolenslaan 107B ; GL SIttard Limburg, 6136 NL
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04260441452622 CardioTek B.V.	EP-TRACER	2024-11-26
GUDID 04260441455326 CardioTek B.V.	EP-TRACER	2021-02-11
GUDID 04260441455425 CardioTek B.V.	EP-TRACER	2020-09-22
GUDID 04260441450482 CardioTek B.V.	Adapter cables unipolar/ bipolar (set of 10)	2020-02-25
GUDID 04260441450574 CardioTek B.V.	Aluminium carrying case	2020-02-07
GUDID 04260441455418 CardioTek B.V.	EP-TRACER	2020-01-28
PMN K183266 | DQK CARDIOTEK BV [Schwarzer Cardiotek GmbH]	EP-TRACER	2019-07-01
PMN K161245 | DQK CARDIOTEK BV [Schwarzer Cardiotek GmbH]	EP-Tracer System	2018-12-04
PMN K134044 | DQK CARDIOTEK BV [Schwarzer Cardiotek GmbH]	EP Tracer	2015-02-17
PMN K134044 CARDIOTEK, B.V.	EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM	2014-03-31