Keystone Medical
Country not established
- Devices
- 2
What Keystone Medical makes
Keystone Medical manufactures central venous catheters, including double-lumen soft-line catheters (e.g., Schon XL and Duo-Flow variants) and peripherally inserted central catheter (PICC) lines. These devices are designed for vascular access in clinical settings, supporting fluid administration, medication delivery, and monitoring.
The company’s products fall under FDA Class II medical devices, with regulatory clearance obtained via 510(k) submissions. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
KEYST0NE Medical Picc Catheter Ref K011860
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Keystone Medical have in the registry?
The registry currently lists 2 devices for Keystone Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Keystone Medical's devices?
Among its 2 most recently registered devices, Keystone Medical has devices listed in FDA 510(k) (2 devices).
What risk classes do Keystone Medical's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Keystone Medical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Keystone Medical in the registry?
The most recently registered devices listed for Keystone Medical include KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH and KEYST0NE MEDICAL PICC CATHETER.