Catheter, Electrode Recording, Or Probe, Electrode Recording

Device Code: 746

Product Code(s): DRF

Device Classification Information

Device Type ID746
Device NameCatheter, Electrode Recording, Or Probe, Electrode Recording
Regulation DescriptionElectrode Recording Catheter Or Electrode Recording Probe.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Electrophysiology Devices Branch (CEDB)
Submission Type510(k)
CFR Regulation Number870.1220 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDRF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID746
DeviceCatheter, Electrode Recording, Or Probe, Electrode Recording
Product CodeDRF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrode Recording Catheter Or Electrode Recording Probe.
CFR Regulation Number870.1220 [🔎]
Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
 
SUBSTANTIALLY EQUIVALENT
 3
INNOVATIVE HEALTH, LLC.
 
SUBSTANTIALLY EQUIVALENT
 2
MEDFACT ENGINEERING GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MEDTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
RHYTHMIA MEDICAL, INC
 
SUBSTANTIALLY EQUIVALENT
 1
ST. JUDE MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
SYNAPTIC MEDICAL LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Adverse Event Without Identified Device Or Use Problem
 630
Appropriate Term/Code Not Available
 97
Catheter
 78
Material Twisted / Bent
 78
Kinked
 70
Break
 36
Material Deformation
 36
Entrapment Of Device
 33
Difficult To Remove
32
Detachment Of Device Component
 26
Material Integrity Problem
 23
Device Sensing Problem
 21
Electrode
 21
Fracture
 19
Insufficient Information
 19
Device Contamination With Chemical Or Other Material
 17
Material Separation
 17
Signal Artifact
 16
Device Operates Differently Than Expected
 15
Failure To Sense
14
Detachment Of Device Or Device Component
 14
Fluid Leak
 13
Positioning Problem
 10
Tip
 10
Device Displays Incorrect Message
10
Failure To Capture
 8
Temperature Problem
 8
Device Issue
 7
Mechanical Jam
 7
Knotted
 7
Bent
 7
Shaft
 7
Material Frayed
 7
Material Split, Cut Or Torn
 7
Electrical /Electronic Property Problem
 6
High Impedance
 5
Device Dislodged Or Dislocated
 5
No Display / Image
 5
Contamination During Use
 5
Sticking
 5
Device Damaged By Another Device
 5
Hole In Material
 5
Improper Flow Or Infusion
 5
Mechanical Problem
 5
Failure To Unfold Or Unwrap
 4
Torn Material
 4
Sharp Edges
 4
Image Display Error / Artifact
 4
Cover
 4
Poor Quality Image
4
Expiration Date Error
 4
Device Operational Issue
 4
Degraded
 4
Wire
 4
Inadequate Storage
 3
Connection Problem
 3
Delivered As Unsterile Product
 3
Use Of Device Problem
 3
Activation, Positioning Or Separation Problem
 3
No Apparent Adverse Event
 3
Infusion Or Flow Problem
 3
Device Inoperable
 3
Defective Component
 3
Fail-Safe Did Not Operate
 3
Leak / Splash
 3
Device Packaging Compromised
 3
Device Damaged Prior To Use
3
Difficult To Advance
 3
Impedance Problem
 3
Difficult To Insert
 3
Device Alarm System
 3
Pacing Problem
 3
Packaging Problem
 3
Noise, Audible
 3
Difficult To Open Or Remove Packaging Material
 3
Difficult To Position
 3
Crack
 3
Display Or Visual Feedback Problem
 3
Device Expiration Issue
 2
Charred
 2
Unable To Obtain Readings
2
Manufacturing, Packaging Or Shipping Problem
 2
Insufficient Flow Or Under Infusion
 2
Excess Flow Or Over-Infusion
 2
Air Leak
 2
Positioning Failure
2
Dent In Material
 2
Device Contaminated During Manufacture Or Shipping
 2
Issue With Displayed Error Message
 2
Power Conditioning Problem
 2
Battery Problem
 2
Tear, Rip Or Hole In Device Packaging
 2
Wrinkled
 2
Communication Or Transmission Problem
 2
Cable
 2
Inflation Problem
 2
Difficult To Open Or Close
 2
Loss Of Or Failure To Bond
 2
Material Puncture / Hole
 2
Contamination / Decontamination Problem
2
Total Device Problems 1627
Recalls
Manufacturer Recall Class Date Posted
1
Arrow International Inc
 II Sep-19-2018
2
Biosense Webster, Inc.
 II Apr-27-2015
3
Biosense Webster, Inc.
 II Mar-03-2015
4
Boston Scientific Corp
 II Dec-10-2014
5
Medtronic Inc.
 II Nov-02-2015
6
St Jude Medical
 II Nov-06-2014
TPLC Last Update: 2019-04-02 19:40:28
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