Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043892

FEI Number

3002808050

Entity Name

BIOTRONIK AG

City/State/Country

BULACH Zurich, CH

Establishment Address

ACKERSTRASSE 6, BULACH Zurich CH-8180, CH

Establishment Type(s)

Manufacture Medical Device

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

P160025

All Registered Proprietary Names

Cruiser-18 Galeo Oscar Pantera Leo Passeo-14 Pantera Pro Passeo-18 Passeo-35 Xeo Orsiro Orsiro Mission PRO-Kinetic Energy Astron Pulsar-18 Pulsar-18 T3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-07-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-06-03
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2025-04-08
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2025-04-08
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2019-02-22
MAF	Stent, Coronary	Unknown	Class 3	N/A	2017-02-22
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
3011574793	CORTRONIK GmbH	Rostock-Warnemuende Mecklenburg-Western Pomerania, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043892. Last updated year: 2026. Please use registration number 8043892 when referencing this establishment in official correspondence.