Valved Peelable Introducer

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

510(k) Number

K021004 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Medamicus Flowguard Peelable Introducer

  Class II

  FDA 510(k) K040150 Active Cleared 18 Feb 2004

• Lumax (Modification)

  Class II

  FDA 510(k) K953734 Active Cleared 18 Jan 1996

• Introducer, Percutaneous -- Modification

  Class II

  FDA 510(k) K924491 Active Cleared 18 Nov 1992

• Medamicus Axia RSN

  Class II

  FDA 510(k) K020563 Active Cleared 21 May 2002

• Modification to Medamicus Axia RSN

  Class II

  FDA 510(k) K022689 Active Cleared 23 Aug 2002

• Transducer, Pressure, Catheter Tip

  Class II

  FDA 510(k) K920580 Active Cleared 7 Jan 1993

See all devices from Medamicus, Inc. →

• What types of procedures is the Valved Peelable Introducer designed to assist with, and why is the one-way valve important during these procedures?

  The Valved Peelable Introducer is specifically designed for use in electrophysiology or cardiac catheterization labs to facilitate the insertion of pacing leads or catheters into the venous system. The one-way valve is critical because it helps minimize the risk of air embolism—a dangerous condition where air enters the bloodstream—during catheter placement, ensuring safer procedural outcomes.

• Is the Valved Peelable Introducer meant for repeated use, or is it intended to be used only once and then discarded?

  The Valved Peelable Introducer is explicitly supplied as a single-use device. This design choice ensures sterility and reduces the risk of contamination or infection, which is particularly important in sterile procedural environments like cardiac catheterization labs.

• How should the Valved Peelable Introducer be stored before use, and what does ‘peelable’ refer to in its design?

  The device must be stored within its sterile packaging until use to maintain sterility. The term ‘peelable’ refers to the sheath’s ability to be easily removed (peeled away) after use, allowing for convenient access to the catheter or lead without compromising the sterile field or requiring additional tools.

• Does the Valved Peelable Introducer come with any accessories, and what role does the included flexible guidewire play in its use?

  Yes, the Valved Peelable Introducer is supplied with a flexible guidewire, which aids in the precise insertion and navigation of the sheath into the venous system. The guidewire provides structural support and helps ensure accurate placement of pacing leads or catheters during the procedure.