Reprocessed Steerable Introducer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152090 FDA 510(k)
- FDA Product Code
- PNE 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 Reprocessed Agilis Steerable Introducer is a cardiovascular catheter introducer designed to facilitate the introduction of various cardiovascular catheters into the heart. It functions as a steerable sheath to assist in the precise placement of diagnostic or therapeutic devices during cardiovascular procedures.
This device is reprocessed by Sterilmed, Inc. and is subject to FDA 510K authorization. It is intended for use in a clinical setting by trained medical professionals. Users should refer to specific product codes, including STJ408309, STJ408310, and STJ408324, for identification and expiration information.
Frequently asked questions
What is the Reprocessed Agilis Steerable Introducer used for?
This device is a reprocessed steerable catheter introducer designed to assist trained medical professionals in guiding diagnostic or therapeutic catheters into the heart during cardiovascular procedures. Its steerable sheath helps ensure precise placement, improving procedural accuracy and safety.
How is the Reprocessed Agilis Steerable Introducer supplied?
The device is supplied by Sterilmed, Inc. under specific product codes: STJ408309, STJ408310, and STJ408324. These codes also include expiration information, allowing clinicians to verify product validity before use.
Is the Reprocessed Agilis Steerable Introducer single-use or reusable?
This device is reprocessed for reuse after proper cleaning, sterilization, and inspection by Sterilmed, Inc. It is intended for clinical settings where multiple procedures may require its use, provided it meets reprocessing standards.
What regulatory pathway applies to this device?
The Reprocessed Agilis Steerable Introducer follows the FDA 510K authorization pathway, classified under device class II (PNE product code). It was determined substantially equivalent to a predicate device by the FDA’s Cardiovascular (CV) Advisory Committee in 2016.
How should the device be stored before use?
While specific storage instructions are not detailed in the provided data, reprocessed medical devices like this introducer generally require protection from contamination, moisture, and extreme temperatures. Clinicians should follow Sterilmed, Inc.’s reprocessing protocols and any additional manufacturer guidelines to maintain sterility and functionality.
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: Sterilmed, Inc. recalls · The Recall Desk, Sterilmed Recalls Reprocessed Agilis Steerable Introducers Due to ..., Sterilmed Reprocessed Agilis Steerable Introducer Sheath recalled due ..., Sterilmed, Inc. recalls — full history | ItsRecalled
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152090 | Class II | Active |
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Manufacturer
- Manufacturer
- Sterilmed, Inc.
Sources (1)
- FDA 510(k) K152090 24 fields · synced Oct 1, 2026