Advanced Bifurcation Systems, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Advanced Bifurcation Systems, 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 |
|---|---|---|---|
| P210014 | PMA | SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex | 2021-12-13 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Bifurcation Systems, 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 Advanced Bifurcation Systems, 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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Bifurcation Systems, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Advanced Bifurcation Systems, 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 Advanced Bifurcation Systems, Inc.?
The most frequent FDA product codes under this applicant name are NIQ (Coronary Drug-Eluting Stent, 1).
Next steps
- See all 0 Advanced Bifurcation Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NIQ, Advanced Bifurcation Systems, 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.