2 results
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49ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·May 14, 2025
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·May 14, 2025