Biocompatibles Cardiovascular, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Biocompatibles Cardiovascular, Inc. makes
The company manufactures coronary guide wires and guiding catheters featuring a phosphorylcholine (PC) polymer coating, including 0.014-inch floppy and intermediate guide wires, Hunter 0.014-inch soft guide wires, and 6 French, 7 French, and 8 French guiding catheters.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Hunter 0.014 Inch Super Soft / Hunter O.014 Inch Soft Guide Wires W/Thromboresistant Pc Coating Ref K970938
Regimes: 510(k) Registry: 510(k)6 French, 7 French, And 8 French Guiding Catheters With Phosphorylcholine (Pc) Polymer Coating Ref K962717
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biocompatibles Cardiovascular, Inc. have in the registry?
The registry currently lists 3 devices for Biocompatibles Cardiovascular, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocompatibles Cardiovascular, Inc.'s devices?
Among its 3 most recently registered devices, Biocompatibles Cardiovascular, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Biocompatibles Cardiovascular, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Biocompatibles Cardiovascular, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biocompatibles Cardiovascular, Inc. in the registry?
The most recently registered devices listed for Biocompatibles Cardiovascular, Inc. include 0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING, HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING and 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING.