Peripheral Catheter Insertion Kit

Device Code: 2732

Product Code(s): OWL

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 Kit, As Described In The Guidance Above, Is Under Enforcemen

Device Classification Information

• Device Type ID: 2732
• Device Name: Peripheral Catheter Insertion 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 Kit, As Described In The Guidance Above, Is Under Enforcemen
• 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 Kit, As Described In The Guidance Above, Is Under Enforcemen
• 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 Kit, As Described In The Guidance Above, Is Under Enforcemen
• Regulation Description: Intravascular 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: 880.5200 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: OWL
• 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
• 6-301 ISO 10555-1 Second Edition 2013-06-15
  Intravascular Catheters - Sterile And Single-use Intravascular Catheters - Part 1: General Requirements
• 6-408 ISO 10555-1 Second Edition 2013-06-15
  Intravascular Catheters - Sterile And Single-use Intravascular Catheters - Part 1: General Requirements [Including AMENDMENT 1 (2017)]

Total Product Life Cycle

• Device Type ID: 2732
• Device: Peripheral Catheter Insertion Kit
• Product Code: OWL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Intravascular Catheter.
• CFR Regulation Number: 880.5200 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Vygon U.S.A.	II	May-04-2018

TPLC Last Update: 2019-04-02 20:18:02