Data / Medical devices / United States / Swan Valley Medical, Incorporated
Swan Valley Medical, Incorporated: FDA-registered device maker in Denver, CO, United States, 1 510(k) clearance
Swan Valley Medical, Incorporated is registered with the FDA (registration 3009688853) in Denver, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 26, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009688853
- Address
- 4246 Carson St Unit 102, Denver, CO, United States, 80239
- Owner or operator
- Swan Valley Medical, Incorporated (10041114)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 20, 2017
- Registered through
- 2026
- Brand names listed
- T-SPeC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Suprapubic (And Accessories) | KOB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Catheter, Punch | FEX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 26, 2012 | K120127 | SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM | KOB | Substantially Equivalent | Swan Valley Medical, Incorporated | accessdata.fda.gov |
Compare with other makers
Updated October 26, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.