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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ct biopsy tray
Regulation Description Endomyocardial biopsy device.
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 CodeOFG
Regulation Number 870.4075
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2023 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Crack 1 1
Material Integrity Problem 1 1
Material Fragmentation 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 2 2
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
3 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
10 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
14 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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