Data / Medical devices / United States / Angiosystems, Inc.
Angiosystems, Inc.: FDA-registered device maker in Ducktown, TN, United States, 3 510(k) clearances
Angiosystems, Inc. is registered with the FDA (registration 1037577) in Ducktown, TN, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 6, 1991. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1037577
- Address
- 7 Hopkins PL., Ducktown, TN, United States, 37326
- Owner or operator
- ANGIOSYSTEMS, INC. (1037577)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 23, 1992
- Registered through
- 2026
- Brand names listed
- AngioSystems, SorbX, Tray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Antimicrobial | KKX | 2 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 6, 1991 | K905462 | PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES | LRP | Substantially Equivalent | Angiosystems, Inc. | accessdata.fda.gov |
| January 12, 1987 | K864688 | ARNOLD-KING PRESSURE DRESSING | NAD | Substantially Equivalent | Angiosystems, Inc. | accessdata.fda.gov |
| September 21, 1984 | K843260 | ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE | KKX | Substantially Equivalent | Angiosystems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Shield, Protective, Personnel
- All makers of Tray, Surgical
- All makers of Drape, Surgical, Antimicrobial
- All makers of Dressing, Wound, Occlusive
Updated February 6, 1991. 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.