Transducer, Pressure, Catheter Tip

Device Code: 822

Product Code(s): DXO

Device Type ID	822
Device Name	Transducer, Pressure, Catheter Tip
Regulation Description	Catheter Tip Pressure Transducer.
Regulation Medical Specialty	Cardiovascular
Review Panel	Cardiovascular
Premarket Review	Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB)
Submission Type	510(k)
CFR Regulation Number	870.2870 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	DXO
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Expansion Pilot Program

Device Type ID	822
Device	Transducer, Pressure, Catheter Tip
Product Code	DXO
FDA Device Classification	Class 2 Medical Device
Regulation Description	Catheter Tip Pressure Transducer.
CFR Regulation Number	870.2870 [🔎]

Premarket Reviews
Manufacturer	Decision
ACIST MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES
	SUBSTANTIALLY EQUIVALENT	3
EDWARDS LIFESCIENCES LLC
	SUBSTANTIALLY EQUIVALENT	2
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ST. JUDE MEDICAL (ABBOTT LABORATORIES)
	SUBSTANTIALLY EQUIVALENT	1
ST. JUDE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	103
Detachment Of Device Component	64
Guidewire	49
Fracture	47
Adverse Event Without Identified Device Or Use Problem	33
Break	29
Material Fragmentation	26
Device Contamination With Chemical Or Other Material	23
Tip	16
Detachment Of Device Or Device Component	15
Particulates	14
Leak / Splash	11
Device Handling Problem	10
Entrapment Of Device	8
Peeled / Delaminated	6
Material Separation	5
Kinked	5
Appropriate Term/Code Not Available	5
Incorrect Measurement	5
Shaft	4
Connection Problem	4
Device Operates Differently Than Expected	4
Failure To Advance	4
Sticking	4
Unsealed Device Packaging	3
Difficult To Position	3
Difficult To Remove	3
Communication Or Transmission Problem	2
Material Twisted / Bent	2
Wire	2
Increase In Pressure	2
Delamination	2
Catheter	2
Insufficient Information	2
Display Or Visual Feedback Problem	2
Incorrect Or Inadequate Test Results	2
Positioning Problem	2
Device Alarm System	2
Disconnection	2
Excess Flow Or Over-Infusion	2
Mechanical Jam	2
Material Deformation	2
Pressure Problem	1
Physical Resistance / Sticking	1
Failure To Zero	1
Device Packaging Compromised	1
Hole In Material	1
Difficult To Insert	1
Device Damaged Prior To Use	1
Failure To Disconnect	1
Calibration Problem	1
Stretched	1
Fluid Leak	1
No Device Output	1
Crack	1
Use Of Device Problem	1
Physical Resistance	1
Device Operational Issue	1
Migration Or Expulsion Of Device	1
Bent	1
Fire	1
Contamination During Use	1
Inaccurate Flow Rate	1
Defective Component	1
Tear, Rip Or Hole In Device Packaging	1
Total Device Problems	556

TPLC Last Update: 2019-04-02 19:42:25