Infusyn Therapeutics, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Infusyn Therapeutics, LLC”, 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 |
|---|---|---|---|
| LKK | Pump, Infusion, Implanted, Programmable | 1 | 0 |
Review panels
- General Hospital (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P080012 | PMA | PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM | 2012-02-07 |
Recalls
openFDA lists no recalls under a recalling firm named Infusyn Therapeutics, LLC.
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 Infusyn Therapeutics, LLC (a text match, not an official crosswalk):
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LKK)
- A4220 — Refill kit for implantable infusion pump (via LKK)
- E0783 — Infusion pump system, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.) (via LKK)
- E0782 — Infusion pump, implantable, non-programmable (includes all components, e.g., pump, catheter, connectors, etc.) (via LKK)
Frequently asked questions
How many FDA 510(k) clearances are listed under Infusyn Therapeutics, LLC?
FDA lists 0 510(k) clearances under the applicant name “Infusyn Therapeutics, LLC”, 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 Infusyn Therapeutics, LLC?
The most frequent FDA product codes under this applicant name are LKK (Pump, Infusion, Implanted, Programmable, 1).
Next steps
- See all 0 Infusyn Therapeutics, LLC clearances with predicates and recalls
- Run predicate analysis for product code LKK, Infusyn Therapeutics, LLC'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.