Data / Medical devices / United States / Atl Technology LLC
Atl Technology LLC: FDA-registered device maker in Springville, UT, United States, 1 510(k) clearance
Atl Technology LLC is registered with the FDA (registration 3007015148) in Springville, UT, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 28, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007015148
- Address
- 1335 West 1650 North, Springville, UT, United States, 84663
- Owner or operator
- ATL Technology LLC (10045899)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- July 2, 2019
- Registered through
- 2026
- Brand names listed
- Acessa ProVu System, Stiletto Extended Dwell Catheter 18G 10CM, Stiletto Extended Dwell Catheter 18G 12CM, Stiletto Extended Dwell Catheter 20G 10CM, Stiletto Extended Dwell Catheter 20G 8CM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coagulator, Laparoscopic, Unipolar (And Accessories) | HFG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Midline Catheter | PND | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tracking, Soft Tissue, Intraoperative | OEW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | 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 |
|---|---|---|---|---|---|---|
| September 28, 2018 | K181124 | Acessa ProVu System | HFG | Substantially Equivalent | Acessa Health, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Midline Catheter
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Tracking, Soft Tissue, Intraoperative
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Coagulator, Laparoscopic, Unipolar (And Accessories)
Updated September 28, 2018. 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.