Identifiers
- 510(k) Number
- K152930 FDA 510(k)
- FDA Product Code
- DPW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2100 FDA 510(k)
- Regulation Number
- 870.2100 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PeriFlux6000 is a blood flowmeter classified under the cardiovascular medical specialty. It is designed for measuring blood flow in cardiovascular applications.
The device is supplied as a reusable instrument and has received FDA 510(k) clearance (K152930) as a Class II device with special controls. It was cleared on May 5, 2016, following submission by Perimed AB.
Frequently asked questions
What is the PeriFlux6000 used for?
The PeriFlux6000 is designed for measuring blood flow in cardiovascular applications, as specified in its description under the cardiovascular medical specialty.
Is the PeriFlux6000 a reusable or single-use device?
The PeriFlux6000 is supplied as a reusable instrument, meaning it can be used multiple times after appropriate cleaning and reprocessing, as stated in the device description.
What regulatory clearance does the PeriFlux6000 have?
The PeriFlux6000 has received FDA 510(k) clearance (K152930) as a Class II device with special controls, which was granted on May 5, 2016, following submission by Perimed AB.
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: K152930 FDA 510 (k) - PeriFlux6000 | Perimed AB
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152930 | Class II | Active |
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Manufacturer
- Manufacturer
- Perimed AB
Sources (1)
- FDA 510(k) K152930 24 fields · synced Sep 26, 2026