Distronic Sterile Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Distronic Sterile Products, Inc. makes
Distronic Sterile Products, Inc. manufactures sterile intravenous administration sets, including vented solution sets, Huber infusion sets with Y-sites, and extension sets with integrated filters or check valves. Their portfolio also covers winged and subcutaneous infusion sets, as well as intravascular administration and micro-volume extension sets designed for precise fluid delivery.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Minibore Stopcock Set Ref K954984
Regimes: 510(k) Registry: 510(k)Vented Solution Set Ref K955732
Regimes: 510(k) Registry: 510(k)Core-Resistant Huber Infusion Set With Y-Site Ref K950597
Regimes: 510(k) Registry: 510(k)Intravascular Administration Set Ref K945184
Regimes: 510(k) Registry: 510(k)60 Micro Volume Extension Set W/.22 Micron Filter, 21 Extension Set W/1.2 Mivton Gilyrt, Inj. Site, Clamp Ref K952663
Regimes: 510(k) Registry: 510(k)Extension Set With Check Valve Ref K954983
Regimes: 510(k) Registry: 510(k)Solution Administration Set Ref K952664
Regimes: 510(k) Registry: 510(k)Winged & Subcutaneous Infusion Sets Ref K955709
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Distronic Sterile Products, Inc. have in the registry?
The registry currently lists 8 devices for Distronic Sterile Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Distronic Sterile Products, Inc.'s devices?
Among its 8 most recently registered devices, Distronic Sterile Products, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Distronic Sterile Products, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Distronic Sterile Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Distronic Sterile Products, Inc. in the registry?
The most recently registered devices listed for Distronic Sterile Products, Inc. include MINIBORE STOPCOCK SET, VENTED SOLUTION SET, CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE and INTRAVASCULAR ADMINISTRATION SET.