AngioJet® Spiroflex® VG 106608

GUDID 08714729889441

Thrombectomy Set

BOSTON SCIENTIFIC CORPORATION

Thrombectomy suction catheter

• Primary Device ID: 08714729889441
• NIH Device Record Key: 78a30995-0463-4daf-9710-69ca7c7122bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngioJet® Spiroflex® VG
• Version Model Number: 106608-001
• Catalog Number: 106608
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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	08714729889441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980037

FDA Product Code

• MCX: CATHETER, CORONARY, ATHERECTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-08-05
• Device Publish Date: 2015-04-21

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 00191506055752 - IceSeed™: 2025-02-27 Cryoablation Needle
• 00191506055769 - IceSphere™: 2025-02-27 Cryoablation Needle
• 00191506055776 - IceRod™: 2025-02-27 Cryoablation Needle
• 00191506060138 - OverStitch™: 2025-02-25 Polypropylene Suture
• 00191506049157 - X-Tack™: 2025-02-25 Endoscopic HeliX Tacking System (Gastric)
• 00191506049164 - X-Tack™: 2025-02-25 Endoscopic HeliX Tacking System (Colonic)
• 00191506049188 - NA: 2025-02-25 Suture Cinch - Long
• 00191506060046 - OverStitch™: 2025-02-25 Suture Cinch