TrapIT TRP10015

GUDID 08718481740279

The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft. The shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.

IMDS Operations B.V.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 08718481740279
• NIH Device Record Key: a5c71e2e-5ab3-4292-979b-eb8c7611324d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrapIT
• Version Model Number: TRP10015
• Catalog Number: TRP10015
• Company DUNS: 489997508
• Company Name: IMDS Operations B.V.
• 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: false
• 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	08718481740279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191229

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2022-09-09
• Device Publish Date: 2022-09-01

On-Brand Devices [TrapIT]

• 08718481740279: The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the dis
• 08718481740262: The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the dis