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APEEL CS PLUS CATHETER DELIVERY SYSTEM - 407580

by St. Jude Medical, Daig Division, Inc.

510(k) K051096

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK051096 Date17 May 2005ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DYB
Models / Variants
407580
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Apeel CS Plus Catheter Delivery System is a cardiovascular introducer device designed to facilitate the placement of catheters into the vascular system. It is classified under product code DYB and is intended for use in procedures requiring controlled access to blood vessels. The system includes components that guide and support catheter insertion while minimizing tissue trauma during deployment.

The device is supplied by St. Jude Medical, Daig Division, Inc. and is a Class 2 medical device cleared through the FDA 510(k) pathway under substantially equivalent determination (SESE) on May 17, 2005. It is regulated under 870.1340 as an introducer/catheter device and is intended for single use in clinical settings. The system is available in multiple models (407579, 407580, 407581, 407582) and is stored in sterile packaging to maintain integrity prior to use.

Other devices from St. Jude Medical, Daig Division, Inc.

Questions

AI-generated answers, 21 Sep 2026

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

  • What is the Apeel CS Plus Catheter Delivery System used for?

    It is a cardiovascular introducer designed to facilitate the placement of catheters into the vascular system. It provides controlled access to blood vessels while minimizing tissue trauma during deployment, making it suitable for procedures requiring precise vascular entry.

  • How is the Apeel CS Plus supplied and stored?

    The device is supplied in sterile packaging to maintain integrity prior to use. It should be stored in a clean, dry environment until the time of application to ensure the sterility barrier remains intact and the device is ready for clinical use.

  • Is the Apeel CS Plus reusable or single-use?

    It is intended for single use in clinical settings. Reusing the device could compromise sterility and structural integrity, potentially leading to patient harm or device failure, so it must be discarded after one application.

  • What models are available for the Apeel CS Plus system?

    The system is available in four models: 407579, 407580, 407581, and 407582. These models may vary in specifications to accommodate different clinical needs, though all share the same core design and intended use as vascular introducers.

  • What regulatory pathway was used for clearance?

    The device was cleared through the FDA 510(k) pathway under the substantially equivalent determination (SESE) on May 17, 2005. It is classified under product code DYB and regulated under 870.1340 as an introducer/catheter device, indicating it met the necessary benchmarks for safety and efficacy at the time of clearance.