RoVo Mechanical Thrombectomy System RVHD

GUDID M917RVHD1

RoVo Mechanical Thrombectomy System, Driver

Verge Medical, Inc.

Thrombectomy suction catheter
Primary Device IDM917RVHD1
NIH Device Record Key639d1f61-ab2c-4c3f-b9ab-2c8f5f302d67
Commercial Distribution StatusIn Commercial Distribution
Brand NameRoVo Mechanical Thrombectomy System
Version Model NumberRVHD
Catalog NumberRVHD
Company DUNS078708447
Company NameVerge Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-844-352-7411
Emailcustomerservice@vergemedical.com
Phone1-844-352-7411
Emailcustomerservice@vergemedical.com
Phone1-844-352-7411
Emailcustomerservice@vergemedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the packaged and sealed device in a dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the packaged and sealed device in a dark, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the packaged and sealed device in a dark, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM917RVHD0 [Primary]
HIBCCM917RVHD1 [Package]
Contains: M917RVHD0
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEWPeripheral Mechanical Thrombectomy With Aspiration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-16
Device Publish Date2026-02-06

On-Brand Devices [RoVo Mechanical Thrombectomy System]

M917VRG7513B30RoVo Mechanical Thrombectomy System, Catheter
M917RVHD1RoVo Mechanical Thrombectomy System, Driver

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