Viaseal Valved Peelable Introducer, Model 10866-XXX

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-Xxx

510(k) Number

K063182 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What types of procedures is the Viaseal Valved Peelable Introducer primarily used for, and why is its valved design beneficial during these procedures?

  The Viaseal Valved Peelable Introducer (Model 10866-XXX) is designed for percutaneous venous access in interventional radiology and cardiology settings. Its valved design ensures a secure seal during insertion of pacing leads or catheters, preventing backflow or contamination—critical for maintaining procedural sterility and patient safety. The peelable sheath also simplifies removal after use, reducing procedural time and improving patient comfort.

• Is this device reusable, or is it intended for single-use only? How does this affect its handling and storage?

  The Viaseal Valved Peelable Introducer is explicitly intended for single-use only, as stated in its description. This means it must be discarded after one procedure to avoid contamination risks. Since it is supplied sterile, proper handling—such as keeping the packaging intact until use and adhering to sterile technique—is essential. Storage should follow manufacturer guidelines to preserve sterility until the device is ready for immediate use.

• What sizes or models are available for the Viaseal Valved Peelable Introducer, and how would I determine the correct size for a patient?

  The Viaseal Valved Peelable Introducer is listed under Model 10866-XXX, but the exact sizes (e.g., French gauge or diameter) are not specified in the provided data. Typically, catheter introducers come in standard sizes like 4F, 5F, or 6F, which should be selected based on the intended catheter or lead size and the patient’s vascular access needs. For precise sizing, consult the manufacturer’s product catalog or clinical guidelines, as improper sizing can lead to complications like vessel trauma or inadequate access.

• How is the regulatory pathway for this device structured, and what does the FDA’s clearance indicate about its use?

  The Viaseal Valved Peelable Introducer holds an FDA 510(k) clearance (K063182) under the product code DYB, classified under regulation 870.1340 for cardiovascular applications. The clearance was granted through the Traditional 510(k) review pathway by the Cardiovascular (CV) Advisory Committee, with a decision dated December 21, 2006. This indicates the device was deemed substantially equivalent to a legally marketed predicate, meaning it meets FDA standards for safety and effectiveness in its intended use for percutaneous venous access in cardiology and interventional radiology.