Identifiers
- 510(k) Number
- K971013 FDA 510(k)
- FDA Product Code
- DTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4400 FDA 510(k)
- Regulation Number
- 870.4400 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Chase Temperature Probe is a Temperature Probe designed for monitoring and regulating temperature during cardiopulmonary bypass procedures. It falls under the classification of a Reservoir, Blood, Cardiopulmonary Bypass device, as defined by regulatory authorities. This probe is intended for precise temperature measurement in blood reservoirs to ensure optimal thermal management during surgical interventions.
The device is supplied as a reusable medical instrument and is regulated under the FDA 510(k) pathway, classified as a Class 2 Cardiovascular device with product code DTN. It is intended for use in controlled clinical settings, such as operating rooms, where accurate temperature control is critical. The probe adheres to regulatory standards outlined in 21 CFR 870.4400 and has been cleared for distribution in the United States. No specific sterility or MRI safety information is provided in the available data.
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: CHASE TEMPERATURE PROBE (K971013) — FDA 510(k) | Innolitics, K971013 FDA 510(k) - CHASE TEMPERATURE PROBE, CHASE TEMPERATURE PROBE 510 (k) K971013 - FDA.report, Chase Medical, Inc. FDA 510 (k) Products (1997-2004)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971013 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chase Medical, Inc.
Sources (1)
- FDA 510(k) K971013 24 fields · synced Oct 1, 2026