EmPro EPS (EP4514C-190, EP6514C-190); Nanoparasol EPS (PNP4514C-190, PNP6514C-190)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222694 FDA 510(k)
- FDA Product Code
- NTE FDA 510(k)
- Models / Variants
- EmPro EPS (EP4514C-190, EP6514C-190) FDA 510(k)Nanoparasol EPS (PNP4514C-190, PNP6514C-190) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EmPro EPS and Nanoparasol EPS are temporary carotid catheters for embolic capture. These devices are designed to function as percutaneous catheters within the cardiovascular system.
These devices are supplied by MicroVention, Inc. and have received FDA 510(k) clearance under K222694. They are classified as Class II medical devices under regulation number 870.1250.
Frequently asked questions
What are the EmPro EPS and Nanoparasol EPS devices used for?
These devices are temporary carotid catheters specifically designed for embolic capture. They function as percutaneous catheters within the cardiovascular system to assist in clinical procedures.
What is the regulatory status of these catheters?
The EmPro EPS and Nanoparasol EPS have received FDA 510(k) clearance under K222694. They are classified as Class II medical devices under regulation number 870.1250.
Which specific models are available for these catheters?
The available models include the EmPro EPS (EP4514C-190 and EP6514C-190) and the Nanoparasol EPS (PNP4514C-190 and PNP6514C-190).
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: EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190 ..., EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190 ..., PDF April 27, 2023 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222694 | Class II | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA 510(k) K222694 24 fields · synced Sep 26, 2026