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Peel-Away Introducer - 405120

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230283

by Abbott Medical

Identifiers

510(k) Number
K230283 FDA 510(k)
FDA Product Code
DYB FDA 510(k)
Models / Variants
405104 FDA 510(k)
405108 FDA 510(k)
405112 FDA 510(k)
405116 FDA 510(k)
405118 FDA 510(k)
405119 FDA 510(k)
405120 FDA 510(k)
405122 FDA 510(k)
405124 FDA 510(k)
405128 FDA 510(k)
405129 FDA 510(k)
405136 FDA 510(k)
405144 FDA 510(k)
405145 FDA 510(k)
405146 FDA 510(k)
405147 FDA 510(k)
405149 FDA 510(k)
405153 FDA 510(k)
405154 FDA 510(k)
405254 FDA 510(k)
405269 FDA 510(k)
405270 FDA 510(k)
405404 FDA 510(k)
405408 FDA 510(k)
405412 FDA 510(k)
405416 FDA 510(k)
405418 FDA 510(k)
405420 FDA 510(k)
405422 FDA 510(k)
405424 FDA 510(k)
405428 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 Peel-Away Introducer is a medical device designed to provide a transvenous conduit for the introduction of cardiac leads and catheters into the venous vascular system. It is utilized during cardiac surgery procedures for patients indicated for cardiac rhythm management devices to treat heart failure, arrhythmias, or cardiac conduction abnormalities.

This device is available in multiple model configurations including 405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, and 405428. The product has received FDA 510(k) clearance.

Frequently asked questions

What is the primary clinical purpose of the Peel-Away Introducer?

This device is designed to create a transvenous conduit that allows for the introduction of cardiac leads and catheters into the venous vascular system. It is specifically used during cardiac surgery for patients requiring rhythm management devices to address heart failure, arrhythmias, or conduction abnormalities.

Which model configurations are available for this introducer?

The device is available in a wide range of model configurations to suit different procedural needs, including models 405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, and 405428.

Has this device received regulatory clearance?

Yes, the Peel-Away Introducer manufactured by Abbott Medical has received FDA 510(k) clearance under the K-number K230283.

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: Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119 ..., PDF 405422, 405424, 405428 Peel-Away Introducer Instructions for Use, peel-away introducer 405104 405108 405112 405116 405118 405119 405120 ..., PDF K230283 Peel-Away Introducer (405104, 405108, 405112, 405116, 405118 ..., St. Jude Medical 405112 SJM™ Peel-Away Introducer Kit

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Medical

Sources (1)

  • FDA 510(k) K230283 24 fields · synced Oct 6, 2026