Devices

Device Recall Galt Valved Tearaway Kit

Model / Serial
Catalot Numbers: KIT-043-06, KIT-043-07, KIT-043-08, KIT-043-09, KIT-043-10, KIT-043-11, KIT-053-06, KIT-053-07, KIT-053-08, KIT-053-09, KIT-053-10, KIT-053-11, KIT-053-12, KIT-053-17, KIT-053-18, KIT-053-19, KIT-053-20, KIT-053-21, and KIT-053-22
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
Product Description
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO || Product Usage: || Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
Manufacturer
Galt Medical Corporation
1 Event
- Recall of Device Recall Galt Valved Tearaway Kit

Manufacturer

Galt Medical Corporation

Manufacturer Address
Galt Medical Corporation, 2220 Merritt Dr, Garland TX 75041-6137
Manufacturer Parent Company (2017)
Juniper Holdings Inc.
Source
USFDA

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