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Implantible Suture Sleeve

by Intermedics, Inc. 510(k)

Active United States

510(k) K820487

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820487 Date16 Apr 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DTB
Device Class
Class III
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Implantable Suture Sleeve is a device classified under the nomenclature for Permanent Pacemaker Electrode components, designed to protect and secure pacemaker leads during surgical implantation. It serves as a protective barrier between the lead body and sutures, reducing mechanical stress and preventing damage from direct suturing. This sleeve helps minimize acute and chronic slippage of the lead, ensuring stable fixation within the body.

The Implantable Suture Sleeve is intended for use in cardiovascular procedures, specifically for securing pacemaker leads during implantation. Supplied as a single-use device, it is sterilized and packaged for sterile application in the operating room. The device is regulated under FDA 510(k) clearance (K820487) and falls under Class III medical device classification (DTB). No additional regulatory status beyond the stated FDA clearance is implied.

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