Product Classification

• Device: system, catheter control, reprocessed
• Regulation Description: Steerable catheter control system.
• Definition: Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: NKR
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: 510(k)
• Regulation Number: 870.1290
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc