Medtronic Model 9410 Teletrace Receiver
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K791778 FDA 510(k)
- FDA Product Code
- DXH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2920 FDA 510(k)
- Regulation Number
- 870.2920 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Model 9410 Teletrace Receiver is a transmitter and receiver, electrocardiograph, telephone device classified under product code DXH. It is a cardiovascular medical device that received FDA 510(k) clearance as substantially equivalent to a predicate device.
It was cleared for marketing on October 2, 1979, under traditional 510(k) pathway K791778 by Medtronic Vascular. The device is regulated as a Class II medical device with special controls and is intended for use in cardiovascular applications.
Frequently asked questions
What is the Medtronic Model 9410 Teletrace Receiver used for?
The Medtronic Model 9410 Teletrace Receiver is a transmitter and receiver electrocardiograph telephone device intended for use in cardiovascular applications, as indicated by its FDA 510(k) clearance and product code DXH classification under transmitters and receivers, electrocardiograph, telephone.
How was the Medtronic Model 9410 Teletrace Receiver cleared for marketing?
The device received FDA 510(k) clearance through the traditional pathway as substantially equivalent to a predicate device, with clearance granted on October 2, 1979, under K791778 by Medtronic Vascular, and is regulated as a Class II medical device with special controls.
What regulatory classification applies to the Medtronic Model 9410 Teletrace Receiver?
The device is classified as a Class II medical device under FDA regulation, with product code DXH and regulation number 870.2920, and was cleared via traditional 510(k) pathway K791778 as substantially equivalent to a predicate device.
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: MEDTRONIC MODEL 9410 TELETRACE RECEIVER (K791778) — FDA 510 (k ..., PDF K791778 - Medtronic Model 9410 Teletrace Receiver, Medtronic Manuals: Home, K781986 - TRANSMITTER | FDA 510 (k) | Medtronic Vascular, MEDTRONIC MODEL 9410 TELETRACE RECEIVER (K791778) — 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 | K791778 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K791778 24 fields · synced Oct 6, 2026