Biotronik AG: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Biotronik AG” (first 2005, latest 2005), plus 4 PMA decisions, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
| MAF | Stent, Coronary | 1 | 0 |
| NIO | Stent, Iliac | 1 | 0 |
| NIP | Stent, Superficial Femoral Artery | 1 | 0 |
| NIQ | Coronary Drug-Eluting Stent | 1 | 0 |
Review panels
- Cardiovascular (5)
Most recent Biotronik AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052757 | PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER | LIT | 2005-10-28 | 28 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170030 | PMA | ORSIRO Sirolimus Eluting Coronary Stent System | 2019-02-22 |
| P160025 | PMA | ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM | 2017-03-23 |
| P160003 | PMA | PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM | 2017-02-14 |
| P140030 | PMA | ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM | 2015-12-17 |
Recalls
openFDA lists no recalls under a recalling firm named Biotronik AG.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Biotronik AG is the lead sponsor of 26 device studies on ClinicalTrials.gov (7 active or recruiting). Most recent:
- NCT07091682: Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions (Recruiting, started 2025-02-18)
- NCT06758921: Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First) (Recruiting, started 2024-12-19)
- NCT05540223: Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System (Recruiting, started 2024-05-13)
- NCT04830228: BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions (Active not recruiting, started 2021-08-10)
- NCT04679740: Resorbable Magnesium Scaffolds Registry (Recruiting, started 2020-11-18)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biotronik AG (a text match, not an official crosswalk):
- C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biotronik, Inc. (103 510(k)s)
- Biotronik Sales, Inc. (41 510(k)s)
- Biotronik Cardiac Pacemakers (3 510(k)s)
- Biotronik GmbH & Co. KG (0 510(k)s)
- Biotronik Nro, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biotronik AG?
FDA lists 1 510(k) clearance under the applicant name “Biotronik AG” (first 2005, latest 2005), plus 4 PMA decisions, across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biotronik AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotronik AG is 28 days.
Which FDA product codes appear under Biotronik AG?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 1); MAF (Stent, Coronary, 1); NIO (Stent, Iliac, 1).
Next steps
- See all 1 Biotronik AG clearances with predicates and recalls
- Run predicate analysis for product code LIT, Biotronik AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.