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TrapIt

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191229

by IMDS Operations B.V.

Identifiers

510(k) Number
K191229 FDA 510(k)
FDA Product Code
DQY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TrapIt Trapping Balloon Catheter is a percutaneous coronary intervention device designed to securely trap guidewires within guiding catheters. Its primary function is to facilitate the efficient exchange of over-the-wire (OTW) catheters during coronary procedures by providing a controlled mechanism for wire retention.

This device is supplied as a single-use, non-sterile catheter with a 100 cm shaft featuring a tactile feedback stop for precise positioning. The integrated balloon, inflated via a lumen using contrast medium, is positioned at the distal tip to secure wires. The TrapIt is classified under FDA product code DQY and was cleared through a Traditional 510(k) pathway, with clearance granted on January 21, 2020.

Frequently asked questions

What is the primary purpose of the TrapIt Trapping Balloon Catheter during coronary procedures?

The TrapIt Trapping Balloon Catheter is designed to securely trap guidewires within guiding catheters, enabling smooth and controlled exchange of over-the-wire (OTW) catheters. This helps streamline coronary interventions by providing a reliable method to retain the wire in place while switching equipment.

Is the TrapIt catheter reusable or intended for single-use, and what does that mean for my workflow?

The TrapIt is explicitly supplied as a single-use device, meaning it is intended for one procedure only. This design choice reduces the risk of cross-contamination and simplifies inventory management, as you won’t need to clean or reprocess it between cases.

How is the TrapIt positioned within the guiding catheter, and what features help ensure accuracy?

The TrapIt features a 100 cm shaft with a tactile feedback stop at the distal end, allowing clinicians to feel precise positioning relative to the guiding catheter. The integrated balloon at the tip is inflated via a lumen using contrast medium to securely trap the guidewire, ensuring controlled retention during catheter exchange.

Is the TrapIt sterile, and if not, what precautions should I take when handling it?

The TrapIt is non-sterile as supplied. To maintain sterility during use, follow standard aseptic techniques, such as using sterile gloves and ensuring the balloon inflation lumen is only accessed with sterile contrast medium. Sterilization is not recommended for reuse, as it is designed for single-use only.

What regulatory pathway was followed for FDA clearance of the TrapIt, and what does that mean for its safety and equivalence?

The TrapIt was cleared through a Traditional 510(k) pathway under FDA product code DQY, with a decision of Substantially Equivalent (SESE) by the Cardiovascular (CV) Advisory Committee. This means the device was compared to a legally marketed predicate and determined to have the same intended use, indications, and safety risks, ensuring its compliance with FDA standards.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TrapIT Trapping Balloon Catheter - IMDS - Interventional Medical Device ..., IMDS Operations B.V. TRP10015 TrapIT - revmedconnect.com, K191229 FDA 510 (k) - TrapIt | Imds Operations B.V., PDF TrapIt - media-cdn.biotronik.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
IMDS Operations B.V.

Sources (1)

  • FDA 510(k) K191229 24 fields · synced Sep 18, 2026