Syringe, Blood, Sampling, Arterial
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K772338 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Syringe, Blood, Sampling, Arterial is a piston syringe designed for the collection of blood samples from an artery. It functions as a medical device used to facilitate the sampling process for clinical diagnostic purposes.
This device is identified under FDA 510(k) number K772338 and is classified under regulation 880.5860. It is manufactured by C. R. Bard, Inc. and has received FDA 510(k) clearance.
Frequently asked questions
What is the primary function of this arterial blood sampling syringe?
This device is a piston syringe specifically engineered to facilitate the collection of blood samples directly from an artery for clinical diagnostic testing.
Who is the manufacturer of this arterial sampling device?
This device is manufactured by C. R. Bard, Inc., located in McHenry, Illinois, and is identified under FDA 510(k) number K772338.
What is the regulatory status of this syringe?
The device has received FDA 510(k) clearance under the classification regulation 880.5860, following a determination of substantial equivalence.
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: SYRINGE, BLOOD, SAMPLING, ARTERIAL (K772338) — FDA 510 (k) | Innolitics, Syringe, Blood, Sampling, Arterial 510(k) K772338 - FDA.report, PDF K772338 - Syringe, Blood, Sampling, Arterial, SYRINGE, BLOOD, SAMPLING, ARTERIAL (K772338) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K772338 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K772338 24 fields · synced Sep 24, 2026