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Devices
Device Recall Dolphin Inflation Device
Model / Serial
Lot Number 15125173
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to MD, NY, and IL
Product Description
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, || Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
Manufacturer
DeRoyal Industries Inc
1 Event
Recall of Device Recall Dolphin Inflation Device
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Manufacturer
DeRoyal Industries Inc
Manufacturer Address
DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
Manufacturer Parent Company (2017)
Deroyal Industries Inc.
Source
USFDA
Language
English
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