Evans Medical, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Evans Medical, Inc. makes
Evans Medical, Inc. manufactures extension sets for intravenous (IV) therapy, including sterile, single-use lines for fluid administration. Their portfolio includes subcutaneously implanted sets like the Model MC4206, designed for long-term access. The company also produces micron-rated filter sets (0.2 and 1.2 microns) for fluid filtration and non-coring needle admin sets for safe medication delivery.
These devices are classified as Class II under FDA regulations, requiring a 510(k) clearance for market authorisation. The products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Evans Medical Extension Sets Ref K935642
510(k) 510(k)Evans Sub-Q, Model MC4206 Ref K020530
510(k) 510(k)- 510(k) 510(k)
Medical Specialties Non-Coring Needle Admin Sets Ref K935480
510(k) 510(k)
Frequently asked questions
How many devices does Evans Medical, Inc. have in the registry?
The registry currently lists 4 devices for Evans Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Evans Medical, Inc.'s devices?
Among its 4 most recently registered devices, Evans Medical, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Evans Medical, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Evans Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Evans Medical, Inc. in the registry?
The most recently registered devices listed for Evans Medical, Inc. include EVANS MEDICAL EXTENSION SETS, EVANS SUB-Q, MODEL MC4206, 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS and MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS.