Port Introducer Kit

Device Code: 2716

Product Code(s): OKE

Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is

Device Classification Information

• Device Type ID: 2716
• Device Name: Port Introducer Kit
• Physical State: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
• Technical Method: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
• Target Area: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
• Regulation Description: Subcutaneous, Implanted, Intravascular Infusion Port And Catheter.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: Enforcement Discretion
• CFR Regulation Number: 880.5965 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: OKE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized 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

Total Product Life Cycle

• Device Type ID: 2716
• Device: Port Introducer Kit
• Product Code: OKE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Subcutaneous, Implanted, Intravascular Infusion Port And Catheter.
• CFR Regulation Number: 880.5965 [🔎]

TPLC Last Update: 2019-04-02 20:17:50