Product Classification

• Device: percutaneous, implanted, long-term intravascular catheter accessory for catheter position
• Regulation Description: Percutaneous, implanted, long-term intravascular catheter.
• Definition: When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.
• Physical State: stainless steel stylet
• Technical Method: device is placed inside a central venous catheter
• Target Area: blood vessels
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: OMF
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5970
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-273 ISO 23908 First edition 2011-06-11
  Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• 6-507 ISO 23908 Second Edition 2024-12
  Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods

Third Party Review

Not Third Party Eligible