Identity
- Trade Name
- VASCULAR SOLUTIONS DUETT SEALING DEVICE FDA PMA
- Generic Name
- Device, hemostasis, vascular FDA PMA
Identifiers
- PMA Number
- P990037 FDA PMA
- FDA Product Code
- MGB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The D-STAT Flowable Hemostat is a vascular hemostasis device designed to seal femoral arterial puncture sites. It is intended to reduce time to hemostasis and enable early ambulation in patients following diagnostic or interventional endovascular procedures using a 5F–9F introducer sheath with an overall length not exceeding 15.2 cm.
This device is supplied as a single-use, sterile product and is regulated under an FDA Premarket Approval (PMA). It is intended for use in vascular procedures and is classified as a Class III medical device. Storage and handling must comply with sterile medical device protocols to ensure efficacy and safety.
Frequently asked questions
What types of vascular procedures is the D-STAT Flowable Hemostat specifically designed to address, and why is this important for clinicians?
The D-STAT Flowable Hemostat is designed to seal femoral arterial puncture sites in patients who have undergone diagnostic or interventional endovascular procedures using a 5F–9F introducer sheath with an overall length not exceeding 15.2 cm. This is important because it helps reduce the time required to achieve hemostasis, enabling patients to ambulate earlier, which can improve recovery outcomes and reduce hospital stay duration.
Is the D-STAT Flowable Hemostat intended for reuse, or is it meant to be used only once per patient? How does this affect clinical workflow?
The D-STAT Flowable Hemostat is supplied as a single-use, sterile product. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical in vascular procedures where infection control is paramount. Clinicians should follow sterile medical device protocols during storage and handling to preserve its efficacy.
What regulatory pathway does the D-STAT Flowable Hemostat follow, and what does this mean for its use in clinical settings?
The D-STAT Flowable Hemostat is regulated under an FDA Premarket Approval (PMA) process, which is required for Class III medical devices. This means it has undergone rigorous review to ensure safety and effectiveness for sealing femoral arterial puncture sites, providing clinicians with confidence in its performance and compliance with stringent regulatory standards.
Are there specific storage requirements for the D-STAT Flowable Hemostat, and why are these important?
The D-STAT Flowable Hemostat must be stored and handled according to sterile medical device protocols to ensure its efficacy and safety. Since it is a single-use, sterile product, maintaining sterility before use is critical to prevent contamination and ensure reliable performance during vascular procedures.
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 | P990037 | Class III | Active |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA PMA P990037 24 fields · synced Sep 18, 2026