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Datascope 10 Fr Flexisheath Percutaneous Introducer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K973007

by Datascope Corp.

Identifiers

510(k) Number
K973007 FDA 510(k)
FDA Product Code
DYB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1340 FDA 510(k)
Regulation Number
870.1340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 10 Fr Flexisheath Percutaneous Introducer is a catheter introducer (product code DYB) designed to facilitate percutaneous vascular access. It serves as a conduit for the insertion of 9.5 Fr intra-aortic balloon catheters, providing a flexible pathway to minimize trauma during catheter placement.

This device is intended for single-use in clinical settings by healthcare professionals. Supplied sterile, it is classified as a Class II medical device under FDA 510(k) clearance (K973007) and adheres to traditional review standards. The flexible sheath is engineered for compatibility with intra-aortic balloon catheters, ensuring safe and efficient vascular access procedures.

Frequently asked questions

What is the primary purpose of the 10 Fr Flexisheath Percutaneous Introducer in clinical procedures?

The 10 Fr Flexisheath Percutaneous Introducer is designed to create a flexible pathway for vascular access, specifically to guide the insertion of 9.5 Fr intra-aortic balloon catheters. Its flexible sheath helps minimize trauma during catheter placement, making it ideal for procedures requiring safe and efficient access to blood vessels.

Is this device intended for reuse in clinical settings, or is it meant for single-use only?

This device is explicitly intended for single-use in clinical settings. The manufacturer emphasizes its sterile supply and designates it as a disposable medical device, ensuring patient safety and preventing cross-contamination.

How is the 10 Fr Flexisheath Percutaneous Introducer supplied, and what does that mean for its handling?

The device is supplied sterile by the manufacturer, meaning it is pre-sterilized and packaged to maintain sterility until use. This ensures healthcare professionals can immediately deploy it in procedures without additional sterilization steps, reducing the risk of contamination.

What types of catheters is this introducer compatible with, and why is that important?

The 10 Fr Flexisheath is engineered for compatibility with 9.5 Fr intra-aortic balloon catheters, ensuring a secure and smooth insertion process. This specific sizing and design compatibility minimizes friction and trauma during placement, which is critical for procedures like intra-aortic balloon pump therapy.

How was the regulatory pathway for this device determined, and what does that imply about its oversight?

The device underwent a traditional 510(k) review by the FDA’s Cardiovascular (CV) Advisory Committee, with a decision code of SESE (Substantially Equivalent). This implies the device was compared to a legally marketed predicate and found to have the same intended use, indications, and risks, ensuring it meets established safety and effectiveness standards for Class II medical devices.

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: Datascope'S 10 Fr. Flexisheath Percutaneous Introducer, K973007 FDA 510(k) - DATASCOPE'S 10 FR. FLEXISHEATH PERCUTAN..., datascope s 10 fr flexisheath percutaneous introducer

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Datascope Corp.

Sources (1)

  • FDA 510(k) K973007 24 fields · synced Sep 19, 2026