FDA.reportPublic FDA data

FLEX Vessel Prep System

Primary DI
00863656000318
Brand
FLEX Vessel Prep System
Company
Venturemed Group, Inc.
Model
FSC 4-40
Catalog number
FSC 4-40
Device description
FLEX Vessel Prep System, FSC 4-40
Published
2019-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PNOCatheter, Percutaneous, Cutting/Scoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNOCatheter, Percutaneous, Cutting/ScoringCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152789000FLEX SCORING CATHETERVenturemed Group2016-05-25PNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863656000318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863656000318008636560003188636560003180863656000318

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, cutting/scoringA sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery and increase myocardial perfusion, by controlled inflation of a distensible balloon at its distal tip with peripheral cutting/scoring elements (e.g., microsurgical atherotomes) intended to remove stenotic material. The device is typically placed using a guidewire and guiding catheter, and its balloon is inflated by the infusion of liquid through it tubular body. The tube and balloon are typically made of polymer materials and the cutting/scoring elements are typically made of metal [e.g., nickel-titanium alloy (Nitinol)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
027796091
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863656000325FLEX Vessel Prep SystemFSC 4-75FSC 4-752023-04-03
00863656000301FLEX Vessel Prep SystemFSC 4-120FSC 4-1202019-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923533802283Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-21
06923533802313Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-21
06923533802320Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-21
06923533802337Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-21
06923533802344Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-21
06923533802351Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-21
06923533802368Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-21
06923533802375Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-21
06923533802382Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-21
06923533802399Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-21
06923533802290Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-20
06923533802306Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-10-20
00852495008517SerranatorCAGENT VASCULAR, LLCPNO2026-09-29
00852495008524SerranatorCAGENT VASCULAR, LLCPNO2026-09-29
06923533801330Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801347Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801354Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801361Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801378Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801385Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801392Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801408Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801415Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801422Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801439Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801446Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801453Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801460Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801477Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801484Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30