Device product
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Z-1838-2026
Product summary
- Event
- Event 98599
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 39 units
- Official record key
device-enforcement:Z-1838-2026
Official wording
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Code information: 1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.