FDA.reportPublic FDA data

FLEX Vessel Prep System

Primary DI
00863656000301
Brand
FLEX Vessel Prep System
Company
Venturemed Group, Inc.
Model
FSC 4-120
Catalog number
FSC 4-120
Device description
FLEX Vessel Prep System, FSC 4-120
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
00863656000301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863656000301008636560003018636560003010863656000301

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
00863656000318FLEX Vessel Prep SystemFSC 4-40FSC 4-402019-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923533801057Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-05-15
B090XC2201450XO ConstrainZIEN MEDICAL TECHNOLOGIES, INC.PNO2026-02-03
B090XC2201451XO ConstrainZIEN MEDICAL TECHNOLOGIES, INC.PNO2026-02-03
06972253606060PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606084PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606107PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606121PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606145PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606183PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606206PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606220PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606268PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606329PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606343PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606367PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606404PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606428PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606442PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606466PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606480PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253605780PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605797PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605803PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605810PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605827PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605834PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605841PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605858PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605865PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605872PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24