Infarkem Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Infarkem Corp. makes
Infarkem Corp. manufactures infusion sets, including the FLEBOSET 1401 (60 drops/minute) and FLEBOSET 1400 (20 drops/minute) for controlled intravenous fluid administration, as well as IV/0165 infusion sets for fluid delivery systems. The company also produces haemodialysis sets and DIALIFLEX fistula needles designed for vascular access procedures in dialysis patients.
These devices are classified under Class II by the FDA and are recorded in the 510(k) premarket notification registry. Infarkem Corp. is based in the United States.
Catalogue
Fleboset 1401(60 Drops/Mi) And FLEBOSET1400(20) Ref K852606
Regimes: 510(k) Registry: 510(k)Iv/0165 Infusion Set Ref K851336
Regimes: 510(k) Registry: 510(k)Haemodialysis Sets & Dialiflex Fistula Needles Ref K851236
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Infarkem Corp. have in the registry?
The registry currently lists 3 devices for Infarkem Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Infarkem Corp.'s devices?
Among its 3 most recently registered devices, Infarkem Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Infarkem Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Infarkem Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Infarkem Corp. in the registry?
The most recently registered devices listed for Infarkem Corp. include FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20), IV/0165 INFUSION SET and HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES.