Product Classification

• Device: catheter, percutaneous, intraspinal, short term
• Regulation Description: Anesthesia conduction catheter.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: General Hospital
• Product Code: MAJ
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 868.5120
• 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

Recognized Consensus Standard

• 6-495 ISO 20698 First Edition 2018-07
  Catheter systems for neuraxial application - Sterile and single-use catheters and accessories

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