Embrace Hydrogel Embolic System (HES)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Embrace(TM) Hydrogel Embolic System FDA PMA
- Generic Name
- Embolization Agent, Vascular FDA PMA
Identifiers
- PMA Number
- P250003 FDA PMA
- FDA Product Code
- QVG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Embrace Hydrogel Embolic System (HES) is a Class III Embolization Agent, Vascular, designed for the embolization of hypervascular tumors in peripheral arteries measuring 5 mm or larger. This device is intended to occlude blood flow to targeted vascular structures, facilitating the treatment of abnormal blood vessel growths through controlled embolization.
The system is supplied as a sterile, single-use device and is regulated under FDA Premarket Approval (PMA P250003). It is intended for use in clinical settings where vascular access and embolization procedures are performed, adhering to sterile techniques. The device’s registration numbers include 2183828, 1047843, 3017208642, 3012690638, and 3005579300, and it falls under the product code QVG for administrative classification.
Frequently asked questions
What types of hypervascular tumors is the Embrace Hydrogel Embolic System designed to treat, and what size arteries does it target?
The Embrace Hydrogel Embolic System is specifically designed for embolization of hypervascular tumors in **peripheral arteries measuring 5 millimeters or larger**. It is intended to occlude blood flow to targeted vascular structures, helping to control abnormal blood vessel growths in these settings.
Is the Embrace Hydrogel Embolic System reusable, or is it meant for single-use only?
The Embrace Hydrogel Embolic System is supplied as a **sterile, single-use device**, meaning it is intended for one-time use per procedure. This design ensures patient safety and maintains sterility standards required for vascular embolization.
How is the Embrace Hydrogel Embolic System regulated in the U.S., and what administrative details should I know?
The device is regulated under **FDA Premarket Approval (PMA P250003)** and falls under the **product code QVG** for administrative classification. It was approved by the FDA’s **Cardiovascular (CV) Advisory Committee** after review by Instylla, Inc. (Bedford, MA). Registration numbers include 2183828, 1047843, 3017208642, 3012690638, and 3005579300.
Where and how should the Embrace Hydrogel Embolic System be stored before use?
While specific storage instructions are not detailed in the provided data, as a **sterile, single-use device**, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Always follow the manufacturer’s included instructions for optimal preservation until use.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P250003 | Class III | Active |
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Manufacturer
- Manufacturer
- Instylla, Inc.
Sources (1)
- FDA PMA P250003 23 fields · synced Sep 18, 2026