Cleared Traditional

PerQseal Introducers

K252309 · Vivasure Medical Limited · Cardiovascular

Oct 2025

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K252309 is an FDA 510(k) clearance for the PerQseal Introducers, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Vivasure Medical Limited (Galway, IE). The FDA issued a Cleared decision on October 23, 2025, 91 days after receiving the submission on July 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K252309 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2025
Decision Date	October 23, 2025
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF