MedAlliance, LLC: FDA clearances and approvals
MedAlliance, LLC has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OOB | Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250041 | PMA | SELUTION SLR 014 PTCA Drug-Eluting Balloon | 2026-09-18 |
Recalls
openFDA lists no recalls under a recalling firm named MedAlliance, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of MedAlliance, LLC's product codes (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via OOB)
- C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch (via OOB)
- C9603 — Percutaneous transluminal coronary atherectomy, with drug-eluting intracoronary stent, with coronary angioplasty when performed; each additional branch of a major coronary artery (list separately in addition to code for primary procedure) (via OOB)
- C9607 — Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of drug-eluting intracoronary stent, atherectomy and angioplasty; single vessel (via OOB)
Frequently asked questions
How many FDA 510(k) clearances does MedAlliance, LLC have?
MedAlliance, LLC has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does MedAlliance, LLC make?
Its most frequent FDA product codes are OOB (Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter, 1).
Has MedAlliance, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching MedAlliance, LLC. Related entities may recall under other names.
Next steps
- See all 0 MedAlliance, LLC clearances with predicates and recalls
- Run predicate analysis for product code OOB, MedAlliance, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.