Data / Medical devices / Switzerland / Biotronik AG
Biotronik AG: FDA-registered device maker in BULACH Zurich, Switzerland, 6 510(k) clearances and 4 PMA approvals
Biotronik AG is registered with the FDA (registration 8043892) in BULACH Zurich, Switzerland. It lists 11 device types. The FDA files 6 510(k) clearances and 4 PMA approvals under its listings, the newest dated April 4, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043892
- FEI number
- 3002808050
- Address
- Ackerstrasse 6, BULACH Zurich, Switzerland, CH-8180
- Owner or operator
- BIOTRONIK AG (10024585)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- July 22, 2011
- Registered through
- 2026
- Brand names listed
- Astron, Cruiser-18, Fortress, Fortress 5/6F, Galeo, Orsiro, Orsiro Mission, Oscar and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Exporter to the US | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Manufacturer | accessdata.fda.gov |
| Coronary Covered Stent | NIV | f | Manufacturer | accessdata.fda.gov |
| Coronary Drug-Eluting Stent | NIQ | 3 | Manufacturer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Exporter to the US | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Exporter to the US | accessdata.fda.gov |
| Stent, Coronary | MAF | 3 | Manufacturer | accessdata.fda.gov |
| Stent, Iliac | NIO | 3 | Manufacturer | accessdata.fda.gov |
| Stent, Superficial Femoral Artery | NIP | 3 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Exporter to the US | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 4, 2025 | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | LIT | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| January 11, 2016 | K153197 | Fortress Introducer Sheath SYstem | DYB | Substantially Equivalent | Contract Medical International, GmbH | accessdata.fda.gov |
| December 20, 2011 | K113468 | ELM PTA BALLON DILATATION CATHETER | LIT | Substantially Equivalent | Creagh Medical, Ltd. | accessdata.fda.gov |
| February 25, 2011 | K100799 | FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 | DYB | Substantially Equivalent | Contract Medical Intl. GmbH | accessdata.fda.gov |
| September 3, 2010 | K102211 | CRUISER 18 GUIDEWIRE | DQX | Substantially Equivalent | Brivant, Ltd. | accessdata.fda.gov |
| September 25, 2009 | K090193 | CONDUCTOR CORONARY GUIDEWIRE | DQX | Substantially Equivalent | Concert Medical, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 22, 2019 | P170030 | ORSIRO Sirolimus Eluting Coronary Stent System | NIQ | 63 | September 24, 2026 | accessdata.fda.gov |
| March 23, 2017 | P160025 | ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM | NIP | 25 | September 11, 2026 | accessdata.fda.gov |
| February 14, 2017 | P160003 | PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM | MAF | 25 | June 5, 2026 | accessdata.fda.gov |
| December 17, 2015 | P140030 | ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM | NIO | 24 | September 11, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Vessel, For Percutaneous Catheterization
- All makers of Introducer, Catheter
- All makers of Wire, Guide, Catheter
- All makers of Stent, Superficial Femoral Artery
- All makers of Stent, Iliac
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
Updated September 24, 2026. 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.