FDA.reportPublic FDA data

RoVo Mechanical Thrombectomy System

Primary DI
M917RVHD1
Brand
RoVo Mechanical Thrombectomy System
Company
Verge Medical, Inc.
Model
RVHD
Catalog number
RVHD
Device description
RoVo Mechanical Thrombectomy System, Driver
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253730000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253730000RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.2026-01-21QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M917RVHD1PackageHIBCC5In Commercial Distribution
M917RVHD0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the packaged and sealed device in a dark, dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-352-7411customerservice@vergemedical.com

Regulatory Flags#

DUNS number
078708447
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810219610071FLASH Flex Aorto-Ostial Angioplasty SystemFF30AFF30A2026-05-22
00810219610088FLASH Flex Aorto-Ostial Angioplasty SystemFF35AFF35A2026-05-22
00810219610095FLASH Flex Aorto-Ostial Angioplasty SystemFF40AFF40A2026-05-22
00810219610101FLASH Flex Aorto-Ostial Angioplasty SystemFF45AFF45A2026-05-22
00810219610118FLASH Flex Aorto-Ostial Angioplasty SystemFF50AFF50A2026-05-22
M917RVHD0RoVo Mechanical Thrombectomy SystemRVHDRVHD2026-02-06
M917VRG7513B30RoVo Mechanical Thrombectomy SystemVRG7513B3VRG7513B32026-02-06
M917OTW7017BA0FLASH Ostial System OTWOTW7017BAOTW7017BA2016-09-22
M917OAB6019BA0FLASH Ostial SystemOAB6019BAOAB6019BA2016-09-22
M917OAB7019BA0FLASH Ostial SystemOAB7019BAOAB7019BA2016-09-22
M917OCB4014BA0FLASH Ostial SystemOCB4014BAOCB4014BA2016-09-22
M917OCB4514BA0FLASH Ostial SystemOCB4514BAOCB4514BA2016-09-22
M917OCB5019BA0FLASH Ostial SystemOCB5019BAOCB5019BA2016-09-22
M917OAB6014BA0FLASH Ostial SystemOAB6014BAOAB6014BA2016-09-22
M917OTW6012BA0FLASH Ostial System OTWOTW6012BAOTW6012BA2016-09-22
M917OTW7012BA0FLASH Ostial System OTWOTW7012BAOTW7012BA2016-09-22
M917OCB3008BA0FLASH MINI Ostial SystemOCB3008BAOCB3008BA2016-09-22
M917OCB3508BA0FLASH MINI Ostial SystemOCB3508BAOCB3508BA2016-09-22
M917OCB4008BA0FLASH MINI Ostial SystemOCB4008BAOCB4008BA2016-09-22
M917OCB4508BA0FLASH MINI Ostial SystemOCB4508BAOCB4508BA2016-09-22

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00850083646059enVast 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646066enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-03-13
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00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.QEW2026-03-02
M917RVHD0RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
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