Cardiac Pathways Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Cardiac Pathways Corp. makes
Cardiac Pathways Corp. manufactures high-density atrial mapping catheters, including the MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER and its deployment kits, as well as EGM adapter cables for electrophysiological studies. Their product line also includes diagnostic electrophysiology catheters, such as the RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (models 30411 B, C, and D), reference catheters with tracking, and arrhythmia mapping systems (8100/8300 series). Additional offerings include the RADII CATHETER and tracking-enabled reference catheters designed for cardiac mapping procedures.
These devices are classified under Class II in the US and are listed in the FDA’s 510(k) registry. The company operates under US regulatory oversight, adhering to requirements for electrophysiological and diagnostic cardiac catheters.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Arrhythmia Mapping System (8100/8300) Ref K965066
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiac Pathways Corp. have in the registry?
The registry currently lists 5 devices for Cardiac Pathways Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiac Pathways Corp.'s devices?
Among its 5 most recently registered devices, Cardiac Pathways Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Cardiac Pathways Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cardiac Pathways Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiac Pathways Corp. in the registry?
The most recently registered devices listed for Cardiac Pathways Corp. include MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES, MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,, ARRHYTHMIA MAPPING SYSTEM (8100/8300) and CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH.