Pathfinder

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K955802 ↗

FDA Product Code

DRF

Device Class

Class II

Regulation

21 CFR Part 870.1220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter

  Class II

  FDA 510(k) K973298 Active Cleared 26 Jun 1998

• Naviport Deflectable Tip Guiding Catheter

  Class II

  FDA 510(k) K974683 Active Cleared 22 Jun 1999

• Tracer O-T-W Mapping Device

  Class II

  FDA 510(k) K972803 Active Cleared 11 May 1999

• Electrode Switchbox, Model 11-081002

  Class II

  FDA 510(k) K982835 Active Cleared 29 Oct 1998

• Modification to: Cardima Ablation System

  Class II

  FDA 510(k) K060715 Active Cleared 15 May 2006

• Cardima Pathfinder 1.5F Mapping Microcatheter

  Class II

  FDA 510(k) K971975 Active Cleared 1 Jul 1998

See all devices from Cardima, Inc. →

• What is the Pathfinder Mapping Microcatheter used for?

  The Pathfinder Mapping Microcatheter is designed specifically for intracardiac electrogram recording and pacing during diagnostic electrophysiology studies. Its primary purpose is to map cardiac electrical activity, including arrhythmias and conduction pathways, by recording detailed signals within coronary vessels and cardiac chambers. The small diameter (3mm) allows for precise navigation, ensuring accurate data collection for diagnostic evaluation.

• Is the Pathfinder Mapping Microcatheter sterile when supplied?

  No, the Pathfinder Mapping Microcatheter is supplied as a non-sterile device. It is intended for use in controlled clinical environments, such as electrophysiology labs, where proper sterilization or preparation must be performed prior to use as per clinical protocols. Always follow manufacturer guidelines and institutional procedures for sterilization.

• What size or model configurations are available for the Pathfinder?

  The Pathfinder Mapping Microcatheter is available in a single configuration: a 3mm diameter electrode recording catheter. This specific diameter facilitates precise navigation within coronary vessels and cardiac chambers, making it suitable for detailed mapping procedures. No other sizes or models are referenced in the available data.

• How is the Pathfinder Mapping Microcatheter classified under FDA regulations?

  The Pathfinder Mapping Microcatheter is classified as a Class II medical device under FDA regulations, with a product code of DRF (870.1220). It received 510(k) clearance through a traditional review pathway, demonstrating substantial equivalence to a predicate device. This classification reflects its role as a diagnostic catheter for cardiovascular applications.

• Is the Pathfinder Mapping Microcatheter intended for single-use or reuse?

  The Pathfinder Mapping Microcatheter is explicitly designed for single-use only. As a non-sterile device, it is not intended for reuse after a single procedure. Proper sterilization or preparation must be performed prior to use, and it should be discarded after one use to maintain safety and efficacy in clinical settings.