Identifiers
- 510(k) Number
- K900622 FDA 510(k)
- FDA Product Code
- DXY FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3610 FDA 510(k)
- Regulation Number
- 870.3610 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 5401B Test Cable is a diagnostic cable designed for testing and calibration of implantable pacemaker pulse generators, as classified under the FDA’s Implantable Pacemaker Pulse-Generator category. It facilitates electrical connectivity and signal verification during device testing to ensure proper functionality and safety before implantation.
This cable is supplied as a reusable medical device and is intended for use in clinical or laboratory settings where pacemaker testing is performed. It has received FDA 510(k) clearance under the product code DXY, with a decision date of April 26, 1990. No specific sterility or MRI safety information is provided in the regulatory data, and its dimensions or additional specifications are not detailed beyond the model designation.
Frequently asked questions
What is the primary purpose of the Modified Model 5401B Test Cable in clinical settings?
The Modified Model 5401B Test Cable is specifically designed for testing and calibration of implantable pacemaker pulse generators. It provides the necessary electrical connectivity and signal verification to ensure the pacemaker functions correctly before implantation, helping to confirm safety and performance in controlled environments like clinical labs or operating rooms.
Is this test cable intended for single-use or can it be reused across multiple procedures?
The Modified Model 5401B Test Cable is classified as a reusable medical device. Since it is used in diagnostic testing rather than direct patient contact during implantation, it is engineered for repeated use in clinical or laboratory settings where pacemaker functionality is validated.
How was the regulatory approval for this device determined, and what does that mean for its use?
The device received FDA 510(k) clearance under the Implantable Pacemaker Pulse-Generator category, with a decision dated April 26, 1990. The clearance was granted as *substantially equivalent* to a predicate device, meaning the FDA determined it has the same intended use and technological characteristics as a previously approved product. This classification allows it to be legally marketed for its specified diagnostic purpose in the U.S.
Are there any specific storage requirements or handling instructions mentioned for this test cable?
The regulatory data does not provide explicit storage instructions or sterility requirements for the Modified Model 5401B Test Cable. Since it is reusable and designed for clinical/laboratory use, proper cleaning and maintenance protocols should be followed to ensure functionality and longevity. Always refer to the manufacturer’s instructions for detailed handling and care guidelines.
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: K900622 FDA 510(k) - MODIFIED MODEL 5401B TEST CABLE, Medtronic Model 5401b Test Cable - Medtronic Vascular | FDA Reference, MODIFIED MODEL 5401B TEST CABLE (K900622) — FDA 510 (k) | Innolitics, Modified Model 5401b Test Cable 510(k) K900622 - FDA.report, MEDTRONIC MODEL 5401B TEST CABLE (K896632) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K900622 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K900622 24 fields · synced Oct 6, 2026