Manometer, Blood-pressure, Venous

Device Code: 858

Product Code(s): KRK

Device Classification Information

• Device Type ID: 858
• Device Name: Manometer, Blood-pressure, Venous
• Regulation Description: Venous Blood Pressure Manometer.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Peripheral Interventional Devices Branch (PIDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.1140 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KRK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 858
• Device: Manometer, Blood-pressure, Venous
• Product Code: KRK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Venous Blood Pressure Manometer.
• CFR Regulation Number: 870.1140 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Carefusion 2200 Inc	II	Apr-18-2018

TPLC Last Update: 2019-04-02 19:43:34