FLEX FSC 4-120

GUDID 00863656000301

FLEX Vessel Prep System Long Basket

VENTUREMED GROUP, INC.

Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring

• Primary Device ID: 00863656000301
• NIH Device Record Key: a8e9f55d-a9fa-4ff4-bd95-410d9cd18a38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEX
• Version Model Number: FSC 4-120
• Catalog Number: FSC 4-120
• Company DUNS: 027796091
• Company Name: VENTUREMED GROUP, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863656000301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152789

FDA Product Code

• PNO: Catheter, Percutaneous, Cutting/Scoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-05
• Device Publish Date: 2019-06-27

Devices Manufactured by VENTUREMED GROUP, INC.

• 00863656000325 - FLEX Vessel Prep System: 2023-04-11 FLEX Vessel Prep System, FSC 4-75
• 00863656000301 - FLEX: 2019-07-05FLEX Vessel Prep System Long Basket
• 00863656000301 - FLEX: 2019-07-05 FLEX Vessel Prep System Long Basket
• 00863656000318 - FLEX AV: 2019-07-05 FLEX Vessel Prep system for arteriovenous fistulae