Vivasure Medical , Ltd.: PMA approval for PerQseal® Elite Vascular Closure Device
Vivasure Medical , Ltd. (Galway): PMA approval for PerQseal® Elite Vascular Closure Device. Dated 19 days ago, it is in the active follow-up window. Score 85/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Vivasure Medical , Ltd. |
| Product | PerQseal® Elite Vascular Closure Device |
| Generic / ingredient | Device, hemostasis, vascular |
| Approval | PMA original approval (new class III device) |
| Application | P250015 |
| Decided | 2026-10-16 |
| Panel / class | Cardiovascular |
| Sponsor location | Galway |
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- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-10-16
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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85 / 100 Score
- Decided in the last 30 days.
- A new product launch.
What is the FdaApprovalPulse record for Vivasure Medical , Ltd. in Galway?
The FDA approved PerQseal® Elite Vascular Closure Device (P250015) for Vivasure Medical , Ltd. on 2026-10-16: PMA original approval (new class iii device).
How does Vivasure Medical , Ltd. compare to other FdaApprovalPulse records?
It is 19 days old, still within a typical 45-day follow-up window. Its Score of 85/100 puts it among the stronger signals in this feed.
Vivasure Medical , Ltd. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Vivasure Medical , Ltd. | Galway | 2026-10-16 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-01 |
| Rejoni, Inc. | Bedford, MA | 2026-09-28 |
| Bard Peripheral Vascular, Inc. | Tempe, AZ | 2026-09-25 |
Related records
FdaApprovalPulse: PMA original approval (new class III device)
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