Merit Siege Vascular Plug

FDA 510(k) K212817 · Merit Medical System, Inc.

Substantially Equivalent

510(k) numberK212817

Submission

Device name
Merit Siege Vascular Plug
Applicant
Merit Medical System, Inc.
South Jordan, UT, US
Received
September 3, 2021
Decision date
December 15, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KRD – Device, Vascular, For Promoting Embolization
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3300
Specialty
Cardiovascular
Implant
Yes

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K261866Concerto Versa™ Detachable CoilKRD · Special Medtronic, Inc.06/24/2026SE
K260635HARBOR Occlusion DeviceKRD · Traditional Nuvascular, Inc.06/12/2026SE
K260508LOBO Vascular Occlusion SystemKRD · Traditional Okami Medical, Inc.04/10/2026SE
K253511Concerto Versa™ Detachable CoilKRD · Traditional Medtronic, Inc.01/14/2026SE
K253677Tembo Embolic SystemKRD · Special Instylla, Inc.12/15/2025SE
K253376OBSIDIO™ Conformable Embolic (M0013972101010)KRD · Special Boston Scientific Corporation10/30/2025SE
K250209Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional Canyon Medical, Inc.09/23/2025SE
K250133HARBOR Occlusion DeviceKRD · Traditional Nuvascular, Inc.07/09/2025SE

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Questions and answers

When was Merit Siege Vascular Plug cleared by the FDA?

Merit Siege Vascular Plug (K212817) received a 510(k) decision of Substantially Equivalent on December 15, 2021, 103 days after the submission was received.

What is the product code of K212817?

The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.