Data / Medical devices / United States / Luther Needlesafe Products LLC
Luther Needlesafe Products LLC: FDA-registered device maker in Laguna Hills, CA, United States, 1 510(k) clearance
Luther Needlesafe Products LLC is registered with the FDA (registration 3017129766) in Laguna Hills, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 30, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017129766
- Address
- 26052 Merit Cir Ste 107, Laguna Hills, CA, United States, 92653
- Owner or operator
- Luther Needlesafe Products LLC (10087391)
- Roles
- Manufacturer
- First device listed
- February 21, 2023
- Registered through
- 2026
- Brand names listed
- Mini-Midline Extended Dwell Peripheral Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | 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 |
|---|---|---|---|---|---|---|
| April 30, 2013 | K130518 | MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER | FOZ | Substantially Equivalent | Luther Needlesafe Products, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 30, 2013. 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.