Search Results
Found 1 results
510(k) Data Aggregation
K Number
K220699Device Name
Prestige Coil System
Manufacturer
Bait USA, LLC
Date Cleared
2022-04-08
(29 days)
Product Code
KRD
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
Bait USA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
Device Description
The Prestige Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize peripheral vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into anomalies to create blood stasis, reducing flow in the target vasculature, and inducing thrombosis. Upon positioning coils into the vasculature, the coils are thermally detached from the delivery pusher in serial manner until the target vasculature is occluded.
Ask a Question
Page 1 of 1