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SEQUENT MEDICAL, INC.

US

Last updated May 27, 2026

What SEQUENT MEDICAL, INC. makes

The company designs and manufactures neurovascular embolization coils, such as the WEB Aneurysm Embolization System, which are used to treat cerebral aneurysms by occluding blood flow. It also produces single-use vascular guide-catheters, including the VIA Microcatheter, for delivering embolic agents to targeted blood vessels. Additionally, it supplies electronic vascular implant detachers, also single-use, for deploying embolization coils within the vascular system.

The portfolio includes devices classified as Class II and Class III under US regulations, with submissions documented through FDA 510(k) and FDA UDIs. These products are intended for use in the United States and are subject to the regulatory requirements of the FDA.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Sequent Medical, Inc. manufacture?

Sequent Medical, Inc. specializes in neurovascular devices. Their portfolio includes embolization coils like the WEB Aneurysm Embolization System, designed to treat cerebral aneurysms by blocking blood flow. They also produce single-use vascular guide-catheters, such as the VIA Microcatheter, which help deliver embolic agents to specific blood vessels. Additionally, they manufacture electronic vascular implant detachers, also single-use, for deploying embolization coils within the vascular system.

Where is Sequent Medical, Inc. based, and what regulatory frameworks apply to their devices?

Sequent Medical, Inc. is based in the United States. Their devices are subject to FDA regulatory requirements, including submissions documented through FDA 510(k) clearances and FDA Unique Device Identifiers (UDIs). The company’s products fall under Class II and Class III classifications, which are determined by the FDA based on risk levels and intended use.

Which regulatory registries or databases list Sequent Medical, Inc.’s devices?

Sequent Medical, Inc.’s devices are documented in the FDA’s 510(k) registry, which tracks premarket submissions for cleared medical devices. Additionally, their products are listed under the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance tracking in the United States.

How are Sequent Medical, Inc.’s devices classified under US regulations?

Sequent Medical, Inc.’s devices are classified as either Class II or Class III under the FDA’s regulatory framework. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices are higher risk and typically require premarket approval due to insufficient data through less stringent classifications. The classification is based on the device’s intended use and potential health impact.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
sequentmedical.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
949.830.9600
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
796807340

Catalogue (224)

Page 1 of 5
DeviceModel / ReferenceRegistriesClassStatus
Sequel Medical IM550038
FDA UDI
Class IIActive
Sequel Medical IM01-1725
FDA UDI
Class IIActive
WEB Aneurysm Embolization System W4-4-3
FDA UDI
Class IIIActive
Sequel Medical IM01-0050
FDA UDI
Class IIActive
Sequel Medical IM01-7002
FDA UDI
Class IIActive
Sequel Medical 102-1001M
FDA UDI
Class IIActive
Sequel Medical IM12220200A
FDA UDI
Class IIActive
Sequel Medical 180-0001
FDA UDI
Class IIActive
Sequel Medical IM15000001
FDA UDI
Class IIActive
Sequel Medical IM12000240A
FDA UDI
Class IIActive
Sequel Medical 140-0002
FDA UDI
Class IIActive
Sequel Medical IM01-0340
FDA UDI
Class IIActive
VIA Microcatheter VIA-17-154-01
FDA UDI
Class IIActive
Sequel Medical IM01-4446
FDA UDI
Class IIActive
Sequel Medical IM13400160SA
FDA UDI
Class IIActive
WEB Aneurysm Embolization System W2-8-S
FDA UDI
Class IIIActive
Sequel Medical IM50000030
FDA UDI
Class IIActive
Sequel Medical IM11800002
FDA UDI
Class IIActive
Sequel Medical IM1600067
FDA UDI
Class IIActive
Sequel Medical 201-1002M
FDA UDI
Class IIActive
Sequel Medical IM12500030
FDA UDI
Class IIActive
WEB Aneurysm Embolization System W2-8-3
FDA UDI
Class IIIActive
Sequel Medical IM11000400
FDA UDI
Class IIActive
Sequel Medical IM1600076
FDA UDI
Class IIActive
Sequel Medical IM11900105
FDA UDI
Class IIActive
VIA Microcatheter VIA-21-154-01
FDA UDI
Class IIActive
Sequel Medical IM11900045
FDA UDI
Class IIActive
Sequel Medical IM01-2060
FDA UDI
Class IIActive
Sequel Medical IM13400180A
FDA UDI
Class IIActive
Sequel Medical 240-0002
FDA UDI
Class IIActive
Sequel Medical IM1600070
FDA UDI
Class IIActive
WEB Aneurysm Embolization System W4-5-4
FDA UDI
Class IIIActive
Sequel Medical IM12600000
FDA UDI
Class IIActive
Sequel Medical IM12200140A
FDA UDI
Class IIActive
Sequel Medical IM11000060
FDA UDI
Class IIActive
Sequel Medical IM13500001
FDA UDI
Class IIActive
Sequel Medical IM12900020
FDA UDI
Class IIActive
Sequel Medical IM60000030
FDA UDI
Class IIActive
Sequel Medical IM12200180A
FDA UDI
Class IIActive
VIA Microcatheter VIA-33-133-01
FDA UDI
Class IIActive
Sequel Medical IM12000130A
FDA UDI
Class IIActive
Sequel Medical IM50000025
FDA UDI
Class IIActive
Sequel Medical IM12200160A
FDA UDI
Class IIActive
Sequel Medical IM60000025
FDA UDI
Class IIActive
Sequel Medical IM12220220A
FDA UDI
Class IIActive
Sequel Medical IM11800001
FDA UDI
Class IIActive
Sequel Medical IM11600003
FDA UDI
Class IIActive
Sequel Medical IM12200150A
FDA UDI
Class IIActive
Sequel Medical IM12600013
FDA UDI
Class IIActive
Sequel Medical 160-0003
FDA UDI
Class IIActive

Related Companies

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Sep 23, 2016Z-0114-2017—terminated

Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.