Medtronic Model 5866-45 Sizing Sleeve
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K890644 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3680 FDA 510(k)
- Regulation Number
- 870.3680 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Model 5866-45 Sizing Sleeve is a Permanent Pacemaker Electrode accessory designed to assist in determining the appropriate size of pacemaker leads for implantation. It provides a standardized method for measuring and selecting the correct lead dimensions to ensure proper fit and function during cardiovascular procedures.
This device is intended for single-use in clinical settings and is supplied sterile. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and holds a Traditional 510(k) clearance (K890644) for use in cardiovascular applications. Storage instructions and MRI safety are not specified in the available data, but it is intended for use with pacemaker leads as part of the implantation process.
Frequently asked questions
What is the primary purpose of the Medtronic Model 5866-45 Sizing Sleeve in a clinical setting?
The Medtronic Model 5866-45 Sizing Sleeve is designed to help clinicians determine the correct size of pacemaker leads before implantation. It provides a standardized way to measure and select the appropriate lead dimensions, ensuring a proper fit and optimal function during cardiovascular procedures.
Is the Medtronic Model 5866-45 Sizing Sleeve intended for reuse or single-use?
The device is explicitly intended for single-use in clinical settings, as stated in the manufacturer’s description. This ensures sterility and reduces the risk of cross-contamination between patients.
How is the Medtronic Model 5866-45 Sizing Sleeve supplied, and what does that mean for handling?
The device is supplied sterile, meaning it is packaged and prepared for immediate clinical use without additional sterilization. This simplifies workflow by eliminating the need for pre-procedure sterilization, though proper handling and storage (as per standard sterile medical device protocols) remain critical.
What regulatory pathway was followed for FDA clearance of this device, and what does that imply for its use?
The Medtronic Model 5866-45 Sizing Sleeve holds a Traditional 510(k) clearance (K890644) under the FDA’s 510(k) program, with a decision of *Substantially Equivalent* to a predicate device. This clearance confirms it meets FDA standards for safety and effectiveness as a Class III medical device (per 21 CFR 870.3680) for use in cardiovascular applications, specifically as an accessory for permanent pacemaker electrodes.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K890644 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K890644 24 fields · synced Oct 6, 2026