FDA.report

FLASH Flex Aorto-Ostial Angioplasty System

Primary DI
00810219610101
Brand
FLASH Flex Aorto-Ostial Angioplasty System
Company
Verge Medical, Inc.
Model
FF45A
Catalog number
FF45A
Device description
FLASH Flex Aorto-Ostial Angioplasty System, 4.5mm x 8mm
Published
2026-05-22
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

Related Records

Product Codes

CodeName
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Premarket Submissions

SubmissionSupplement
K254022000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K254022000FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.2026-04-02LOX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810219610101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810219610101008102196101018102196101010810219610101

GMDN Terms

TermDefinition
Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.

Device Sizes

TypeValueUnit
Balloon Diameter0
Balloon Length0
Catheter Length0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry location at room temperature.

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 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
00810219610118FLASH Flex Aorto-Ostial Angioplasty SystemFF50AFF50A2026-05-22
M917RVHD1RoVo Mechanical Thrombectomy SystemRVHDRVHD2026-02-06
M917VRG7513B30RoVo Mechanical Thrombectomy SystemVRG7513B3VRG7513B32026-02-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810219610071FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610088FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610095FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610118FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
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