Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011574793

FEI Number

3011574793

Entity Name

CORTRONIK GmbH

City/State/Country

Rostock-Warnemuende Mecklenburg-Western Pomerania, DE

Establishment Address

Friedrich-Barnewitz-Str. 4a, Rostock-Warnemuende Mecklenburg-Western Pomerania D-18119, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIOTRONIK AG (Owner Number: 10024585)

Owner / Operator Contact Address

Ackerstrasse 6, Buelach, CH-ZH CH-8180, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PRO-Kinetic Energy Papyrus Astron Pulsar-18 Pulsar-18 T3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAF	Stent, Coronary	Unknown	Class 3	N/A	2017-02-22
NIV	Coronary Covered Stent	Unknown	Class f	N/A	2018-12-26
NIO	Stent, Iliac	Unknown	Class 3	N/A	2015-12-22
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2017-03-28

Official Correspondent

No official correspondent registered.

US Agent Details

Divya Raman Business: Teleflex, Inc Email: FDA.US.Agent@teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

BIOTRONIK AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018805824	BIOTRONIK APM PTE. LTD	Singapore South East, SG
8043892	BIOTRONIK AG	BULACH Zurich, CH

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2014	Bard Peripheral Vascular Inc	3	Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 6.5 mm.

Similar Registrations

Registration Number	Establishment Name	Location
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
9681260	Boston Scientific Limited	GALWAY, IE
3005111382	Boston Scientific International BV, European Dist. Ctr.	KERKRADE Limburg, NL
2024168	ABBOTT VASCULAR	Temecula, CA, US
3002807314	Synergy Health Ireland Ltd	Tullamore Offaly, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011574793. Last updated year: 2026. Please use registration number 3011574793 when referencing this establishment in official correspondence.