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510(k) Data Aggregation
K Number
K241458Device Name
Borvo EVAC System (Ergo); Borvo EVAC System (Classic)
Manufacturer
Borvo Medical Inc.
Date Cleared
2024-08-20
(89 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
Borvo Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVAC is indicated to facilitate the evacuation of a chronic or subacute hematoma or hygroma in the cranium. The EVAC is intended for draining of fluid accumulated in the subdural space, including chronic or subacute hematomas and hygromas. The EVAC is also intended for removing air and fluid from the subdural space following open surgical procedures to remove subdural collections.
Device Description
The Borvo EVAC System is intended for the drainage of subdural fluid accumulations. The EVAC System is designed to gradually drain fluid to an external reservoir by creating a low negative pressure in the subdural space. It consists of 3 components:
- 1. EVAC Port (Ergo or Classic)
- 2. Tubing
- 3. Vacuum bulb
An optional Cranial Access Kit can be purchased with the EVAC System, or a commercially available Cranial Access Kit with a 5.31mm drill bit can be used.
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