Strato Medical Corp.
United StatesFDA applicant, unverified
- Devices
- 46
What Strato Medical Corp. makes
Strato Medical Corp. manufactures vascular access devices, including implantable and non-implantable catheters, infusion pumps, and port systems for central venous access. Products include silicone and polyurethane catheters, pre-attached catheter systems, introducer kits, and specialized infusion components like PCA infusers and piggyback pumps. Some devices incorporate modified designs for specific clinical applications, such as the Wigness-Buchwald catheter or modified port systems for dual-lumen access.
The company’s portfolio is regulated under FDA classifications, with devices falling under Class II and Class U (unclassified) categories. Authorisation records include 510(k) clearances and PMA submissions, reflecting compliance with U.S. medical device regulations. Products are listed in the FDA’s regulatory databases, and the company operates from the United States.
Catalogue
Search and filter all 46 devicesFrequently asked questions
How many devices does Strato Medical Corp. have in the registry?
The registry currently lists 46 devices for Strato Medical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Strato Medical Corp.'s devices?
Among its 46 most recently registered devices, Strato Medical Corp. has devices listed in FDA 510(k) (45 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Strato Medical Corp.'s devices fall under?
Among its 46 most recently registered devices, the classes recorded for Strato Medical Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Strato Medical Corp. in the registry?
The most recently registered devices listed for Strato Medical Corp. include STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED, LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555, STRATOFUSE SYRINGE PIGGYBACK PUMP 1030 and STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION.