Data / Medical devices / United States / Launch Development
Launch Development: FDA-registered device maker in Dalton Gardens, ID, United States, 5 510(k) clearances
Launch Development is registered with the FDA (registration 3011657089) in Dalton Gardens, ID, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011657089
- Address
- 7791 Aqua Circle, Suite 7G, Dalton Gardens, ID, United States, 83815
- Owner or operator
- Launch Development (10049473)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- December 21, 2015
- Registered through
- 2026
- Brand names listed
- CLI-111-00, KIT-072-00
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 1, 2024 | K232858 | ORskin Blue | GEX | Substantially Equivalent | Megabay S.A. | accessdata.fda.gov |
| October 5, 2017 | K172099 | Shoocin Introducer Kit | DYB | Substantially Equivalent | Lepu Medical Technology (Beijing) Co., Ltd. | accessdata.fda.gov |
| October 15, 2014 | K140470 | OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER | GEX | Substantially Equivalent | Oberon GmbH Fiber Technologies | accessdata.fda.gov |
| February 9, 2005 | K043525 | CATHETER INTRODUCER | DYB | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| August 1, 2000 | K000737 | COAXIAL DILATOR SET | DRE | Substantially Equivalent | Xentek Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Powered Laser Surgical Instrument
- All makers of Dilator, Vessel, For Percutaneous Catheterization
Updated May 1, 2024. 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.