Biosensors International USA, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Biosensors International USA, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NIQ | Coronary Drug-Eluting Stent | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P190020 | PMA | BioFreedom Drug Coated Coronary Stent System | 2022-04-14 |
Recalls
openFDA lists no recalls under a recalling firm named Biosensors International USA, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biosensors International USA, Inc. (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.
- Biosensors International-USA (2 510(k)s)
- Biosensors Intl. Pte. , Ltd. (2 510(k)s)
- Biosensors International Pte, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biosensors International USA, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Biosensors International USA, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Biosensors International USA, Inc.?
The most frequent FDA product codes under this applicant name are NIQ (Coronary Drug-Eluting Stent, 1).
Next steps
- See all 0 Biosensors International USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NIQ, Biosensors International USA, Inc.'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.