Controller, Infusion, Intravascular, Electronic

Device Code: 2648

Product Code(s): LDR

Device Classification Information

• Device Type ID: 2648
• Device Name: Controller, Infusion, Intravascular, Electronic
• Regulation Description: Infusion Pump.
• 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: 510(k)
• CFR Regulation Number: 880.5725 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LDR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2648
• Device: Controller, Infusion, Intravascular, Electronic
• Product Code: LDR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Infusion Pump.
• CFR Regulation Number: 880.5725 [🔎]

Device Problems
Excess Flow Or Over-Infusion	21
Insufficient Flow Or Under Infusion	1
Inaccurate Flow Rate	1
Infusion Or Flow Problem	1
Total Device Problems	24

Recalls
Manufacturer		Recall Class	Date Posted
1	ConMed Corporation	II	Feb-28-2018

TPLC Last Update: 2019-04-02 20:16:42