Localmed, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Localmed, Inc. makes
Localmed, Inc. manufactures infusion catheters and related infusion systems, including the InfusaSleeve IIA (IS-2A) and Kaplan-Simpson InfusaSleeve variants, designed for controlled drug delivery in medical procedures. These devices are intended for use in vascular access and infusion applications, such as chemotherapy or other intravenous therapies.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the United States, where Localmed, Inc. is based.
Catalogue
Localmed Infusion Catheter Ref K935349
Regimes: 510(k) Registry: 510(k)Infusasleeve Iia (Is-2A) Ref K972175
Regimes: 510(k) Registry: 510(k)Kaplan-Simpson Infusasleeve Catheter Ref K950615
Regimes: 510(k) Registry: 510(k)Kaplan-Simpson Infusasleeve Ii Ref K980957
Regimes: 510(k) Registry: 510(k)Kaplan-Simpson InfusaSleeve II Catheter Ref K952317
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Localmed, Inc. have in the registry?
The registry currently lists 5 devices for Localmed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Localmed, Inc.'s devices?
Among its 5 most recently registered devices, Localmed, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Localmed, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Localmed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Localmed, Inc. in the registry?
The most recently registered devices listed for Localmed, Inc. include LOCALMED INFUSION CATHETER, INFUSASLEEVE IIA (IS-2A), KAPLAN-SIMPSON INFUSASLEEVE CATHETER and KAPLAN-SIMPSON INFUSASLEEVE II.