FDA.reportPublic FDA data

Verge Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087008173008700817Verge Medical Inc.1N2026-01-01747 Camden Ave Ste A Campbell CA US 95008

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810219610071FLASH Flex Aorto-Ostial Angioplasty System - FLASH Flex Aorto-Ostial Angioplasty System, 3.0mm x 8mm1-844-352-7411customerservice@vergemedical.com
00810219610088FLASH Flex Aorto-Ostial Angioplasty System - FLASH Flex Aorto-Ostial Angioplasty System, 3.5mm x 8mm1-844-352-7411customerservice@vergemedical.com
00810219610095FLASH Flex Aorto-Ostial Angioplasty System - FLASH Flex Aorto-Ostial Angioplasty System, 4.0mm x 8mm1-844-352-7411customerservice@vergemedical.com
00810219610118FLASH Flex Aorto-Ostial Angioplasty System - FLASH Flex Aorto-Ostial Angioplasty System, 5.0mm x 12mm1-844-352-7411customerservice@vergemedical.com
M917RVHD0RoVo Mechanical Thrombectomy System - RoVo Mechanical Thrombectomy System, Driver1-844-352-7411customerservice@vergemedical.com
M917RVHD1RoVo Mechanical Thrombectomy System - RoVo Mechanical Thrombectomy System, Driver1-844-352-7411customerservice@vergemedical.com
M917VRG7513B30RoVo Mechanical Thrombectomy System - RoVo Mechanical Thrombectomy System, Catheter1-844-352-7411customerservice@vergemedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1225601243704856K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemLOX2026-04-02
1225602004081331K253730RoVo Mechanical Thrombectomy SystemQEW2026-01-21
1225602058871668K152485FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cmLOX2016-02-16
1225601901719056K150946FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cmLIT2015-05-08
1225602020658951K133861FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CMLIT2014-07-02
1225601507906315K131450FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0LOX2013-08-06
1225601245631062K122379FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CMLIT2012-09-05
1225601107343952K122178FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1LOX2012-10-11
1225601394640854K120738FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CMLIT2012-03-29
1225601405037456K113775FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MMLOX2012-06-29
1225601276887884

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOX52026-04-02
LIT42015-05-08
QEW12026-01-21

PMN#

GUDID#