Scimed
Country not established
- Devices
- 8
What Scimed makes
Scimed manufactures a range of interventional cardiovascular devices, including guiding catheters (7FR, 8FR, and 6 French micro-guide variants), steerable guide wires, balloon inflation systems (e.g., the SM2500 model), and angiographic catheters. Their portfolio also includes the Sideliner, Viper catheter, and a cardioplegia delivery system for cardiac procedures.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Scimed 6 French Micro-Max Guide Catheter Ref K953909
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Scimed Encore Inflation Device, Model SM2500 Ref K903503
Regimes: 510(k) Registry: 510(k)Scimed Sideliner Ref K922706
Regimes: 510(k) Registry: 510(k)Scimed Angiographic Catheters Ref K992142
Regimes: 510(k) Registry: 510(k)Scimed Viper Catheter Ref K915347
Regimes: 510(k) Registry: 510(k)Scimed Cardiotherm Cardioplegia Delivery System Ref K904171
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scimed have in the registry?
The registry currently lists 8 devices for Scimed. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scimed's devices?
Among its 8 most recently registered devices, Scimed has devices listed in FDA 510(k) (8 devices).
What risk classes do Scimed's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Scimed's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scimed in the registry?
The most recently registered devices listed for Scimed include 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE, SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER, SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS. and SCIMED ENCORE INFLATION DEVICE, MODEL SM2500.