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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiac catheterization kit
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 type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOES
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2019 13 13
2020 35 35
2021 21 21
2022 13 13
2023 18 18
2024 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Break 17 17
Crack 16 16
Material Integrity Problem 13 13
Appropriate Term/Code Not Available 9 9
Unraveled Material 7 7
Failure to Advance 6 6
Device Contamination with Chemical or Other Material 6 6
Material Fragmentation 6 6
Material Frayed 6 6
Physical Resistance/Sticking 6 6
Contamination /Decontamination Problem 6 6
Leak/Splash 5 5
Tear, Rip or Hole in Device Packaging 5 5
Fluid/Blood Leak 4 4
Material Separation 4 4
Material Deformation 4 4
Packaging Problem 4 4
Material Split, Cut or Torn 3 3
Difficult to Insert 3 3
Material Puncture/Hole 3 3
Contamination 3 3
Obstruction of Flow 3 3
Component Missing 3 3
Activation, Positioning or Separation Problem 3 3
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 2 2
Difficult to Advance 2 2
Stretched 2 2
Retraction Problem 2 2
Air/Gas in Device 2 2
Insufficient Information 2 2
Deformation Due to Compressive Stress 2 2
Connection Problem 2 2
Contamination of Device Ingredient or Reagent 1 1
Pressure Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Unexpected Therapeutic Results 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Melted 1 1
Particulates 1 1
Peeled/Delaminated 1 1
Device Dislodged or Dislocated 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Incomplete or Missing Packaging 1 1
Fitting Problem 1 1
Defective Component 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 80 80
Insufficient Information 15 15
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Patient Involvement 6 6
Foreign Body In Patient 2 2
Exposure to Body Fluids 2 2
Death 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Underdose 1 1
Patient Problem/Medical Problem 1 1
Abrasion 1 1
Air Embolism 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Jan-26-2024
3 American Contract Systems, Inc. II Oct-26-2023
4 American Contract Systems, Inc. II Sep-08-2022
5 American Contract Systems, Inc. II May-06-2022
6 Avid Medical, Inc. II Mar-19-2020
7 Centurion Medical Products Corporation II Oct-09-2019
8 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
13 Merit Medical Systems, Inc. II Oct-01-2019
14 ROi CPS LLC II Apr-25-2023
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