Bionomy, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Bionomy, Inc. makes
Bionomy, Inc. manufactures occlusion catheters and multi-lumen central venous catheter-sets for vascular and biliary applications, including embolization and irrigation procedures. Their product line includes arterial occlusion catheters for cholangiocarcinoma treatment and embolectomy catheters for clot removal.
The company’s devices are classified under FDA categories Class I and Class II, with submissions recorded in the FDA’s 510(k) registry. Products are listed under US jurisdiction, adhering to applicable medical device regulations.
Catalogue
Occlusion Catheter Ref K811276
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Pruitt Irrigation And Occlusion Catheter Ref K844094
Regimes: 510(k) Registry: 510(k)Pruitt Arterial Occlusion Cholang. Cath Ref K812111
Regimes: 510(k) Registry: 510(k)Embolectomy Catheter Ref K832023
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bionomy, Inc. have in the registry?
The registry currently lists 5 devices for Bionomy, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bionomy, Inc.'s devices?
Among its 5 most recently registered devices, Bionomy, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Bionomy, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Bionomy, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bionomy, Inc. in the registry?
The most recently registered devices listed for Bionomy, Inc. include OCCLUSION CATHETER, BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET, PRUITT IRRIGATION AND OCCLUSION CATHETER and PRUITT ARTERIAL OCCLUSION CHOLANG. CATH.