Cimpax Aps
DK Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
C-CAT Anaesthesia Catheter kit Ref K191470
What Cimpax Aps makes
Cimpax Aps manufactures the C-CAT Anaesthesia Catheter kit, a device designed for anaesthesia procedures to facilitate precise drug administration and patient monitoring during surgical interventions.
The C-CAT Anaesthesia Catheter kit is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Cimpax Aps manufacture?
Cimpax Aps specializes in the C-CAT Anaesthesia Catheter kit, a device specifically designed for anaesthesia procedures. It is intended to help healthcare providers administer drugs with precision and monitor patients effectively during surgical operations.
Where is Cimpax Aps based?
Cimpax Aps is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach.
How are Cimpax Aps’ devices classified under FDA regulations?
The C-CAT Anaesthesia Catheter kit is classified as a Class II medical device by the FDA. This classification indicates moderate risk and requires compliance with specific controls to ensure safety and effectiveness, including performance standards and post-market surveillance.
Which regulatory registries or pathways list Cimpax Aps’ devices?
The C-CAT Anaesthesia Catheter kit is listed via the FDA’s 510(k) pathway, which demonstrates that the device meets regulatory requirements by showing substantial equivalence to a legally marketed predicate device. This pathway is commonly used for Class II devices.
Information
- Country
- DK