Cleared Traditional

Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)

K240261 · Merit Medical Systems, Inc. · Cardiovascular

May 2024

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K240261 is an FDA 510(k) clearance for the Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027), a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 2, 2024, 92 days after receiving the submission on January 31, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number	K240261 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2024
Decision Date	May 02, 2024
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF