Hospira Latex-Free Critical Care And Advanced Sensor Catheters
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091268 FDA 510(k)
- FDA Product Code
- DQE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1230 FDA 510(k)
- Regulation Number
- 870.1230 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hospira Latex-Free Critical Care And Advanced Sensor Catheters are catheters, specifically oximeter, fiber-optic catheters, used in critical care. They are designed to be latex-free. The device is classified as a catheter and is used in the cardiovascular medical specialty.
The catheters are supplied by Hospira, Inc. and have been found substantially equivalent. They have an FDA 510K authorization, with a clearance type of special, and are classified under regulation number 870.1230. The device has a product code of DQE and is used in settings such as hospitals and clinics.
Frequently asked questions
What are the Hospira Latex-Free Critical Care And Advanced Sensor Catheters used for?
They are used in critical care, specifically as oximeter fiber-optic catheters, in the cardiovascular medical specialty.
Are the Hospira Latex-Free Catheters supplied sterile?
The description does not explicitly state that the catheters are supplied sterile, but they are designed for use in critical care settings.
What is the regulatory classification of the Hospira Latex-Free Catheters?
The device has an FDA 510K authorization, with a clearance type of special, and is classified under regulation number 870.1230 with a product code of DQE.
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: Hospira - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091268 | Class II | Active |
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Manufacturer
- Manufacturer
- Hospira, Inc.
Sources (1)
- FDA 510(k) K091268 24 fields · synced Sep 23, 2026