Identity
- Trade Name
- ARTERX SURGICAL SEALANT FDA PMA
- Generic Name
- Sealant, polymerizing FDA PMA
Identifiers
- PMA Number
- P100030 FDA PMA
- FDA Product Code
- NBE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The ArterX Surgical Sealant is a polymerizing sealant classified as a Sealant, Polymerizing under FDA nomenclature. It is designed to achieve adjunctive hemostasis in vascular reconstructions by mechanically sealing areas of leakage, preventing blood loss at surgical sites.
This device is supplied as a sterile, single-use system in a 4 mL double-barreled syringe package. It is intended for use in operating rooms and is approved under FDA_PMA (P100030). The sealant requires no special storage conditions beyond standard surgical supply protocols and is not MRI-compatible.
Frequently asked questions
What is the primary purpose of the ArterX Surgical Sealant in surgical procedures?
The ArterX Surgical Sealant is designed to provide adjunctive hemostasis during vascular reconstructions by mechanically sealing areas where leakage may occur. This helps prevent blood loss at the surgical site, ensuring better stability and control during procedures involving blood vessels.
How is the ArterX Surgical Sealant packaged and prepared for use in the operating room?
The device comes as a sterile, single-use system in a 4 mL double-barreled syringe package. This packaging ensures sterility and convenience for immediate use in the operating room without requiring additional preparation.
Can the ArterX Surgical Sealant be reused, or is it intended for single-use only?
The ArterX Surgical Sealant is explicitly designed for single-use only. The sterile packaging and polymerizing nature of the sealant make it unsuitable for reuse, ensuring patient safety and efficacy.
Are there any special storage requirements for the ArterX Surgical Sealant beyond standard surgical supply protocols?
No, the ArterX Surgical Sealant does not require any special storage conditions beyond those typically used for surgical supplies. It can be stored under standard operating room conditions until use.
Is the ArterX Surgical Sealant compatible with MRI imaging, or should it be avoided in patients who need MRI scans?
The ArterX Surgical Sealant is explicitly noted as **not MRI-compatible**. If a patient who received this sealant requires an MRI scan, this incompatibility should be considered to avoid potential interference or safety risks.
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: Preveleak - Baxter, PREVELEAK - Baxter specialty Site, PREVELEAK Surgical Sealant 4 mL - ecatalog.baxter.com, PREVELEAK Surgical Sealant 4 mL - catalog.baxter.com, Preveleak Instructions For Use | Baxter Pro US
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100030 | Class III | Active |
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Manufacturer
- Manufacturer
- Baxter Healthcare Corporation
Sources (1)
- FDA PMA P100030 24 fields · synced Oct 6, 2026