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Inner-Lock Locking Introducer Sheaths

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022170

by Rex Medical

Identifiers

510(k) Number
K022170 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 Inner-Lock Locking Introducer Sheaths are vascular access devices consisting of a central lumen, an angled side arm extension, and a hemostasis valve. They are used to facilitate placing a catheter through the skin into a graft. The Inner-Lock dilator is an accessory device that creates an occlusion and provides support to the wall of the indwelling sheath.

The device is manufactured by Rex Medical and was cleared through the FDA 510(k) pathway on January 21, 2003. It is categorized under product code DYB and is available in 6F and 7F sizes. The device is intended for single use and requires proper storage conditions as specified by the manufacturer.

Frequently asked questions

What is the purpose of the Inner-Lock Locking Introducer Sheaths?

The Inner-Lock Locking Introducer Sheaths are vascular access devices used to facilitate placing a catheter through the skin into a graft. They feature a central lumen, an angled side arm extension, and a hemostasis valve.

What sizes are available for the Inner-Lock Locking Introducer Sheaths?

The Inner-Lock Locking Introducer Sheaths are available in two sizes: 6F and 7F. These different size options allow for flexibility in various clinical procedures requiring vascular access.

Are the Inner-Lock Locking Introducer Sheaths reusable or single-use devices?

The Inner-Lock Locking Introducer Sheaths are intended for single use only. After a single procedure, the device should be discarded according to proper medical waste disposal protocols to ensure patient safety and device performance.

What is the Inner-Lock dilator and how does it relate to the introducer sheath?

The Inner-Lock dilator is an accessory device that works with the introducer sheath. It creates an occlusion and provides support to the wall of the indwelling sheath, helping to maintain proper positioning during catheter placement procedures.

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: Inner-Lock Locking Introducer Sheaths - Rex Medical | FDA Reference, INNER-LOCK INTRODUCER SHEATH (K051468) — FDA 510(k) | Innolitics, INNER-LOCK LOCKING INTRODUCER SHEATHS (K022170) — FDA 510(k) - Innolitics, PDF SEP f 6 2003 - accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rex Medical

Sources (1)

  • FDA 510(k) K022170 24 fields · synced Sep 27, 2026