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Sign in to claim this brandSEQUENT 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
- —
- —
- [email protected]
- Phone
- 949.830.9600
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 796807340
Catalogue (224)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sequel Medical | IM1700045 | FDA UDI | Class II | Active |
| Sequel Medical | IM11000200 | FDA UDI | Class II | Active |
| Sequel Medical | IM60000035 | FDA UDI | Class II | Active |
| Sequel Medical | IM12220160A | FDA UDI | Class II | Active |
| Sequel Medical | IM12600002L | FDA UDI | Class II | Active |
| Sequel Medical | IM11800004 | FDA UDI | Class II | Active |
| WEB Aneurysm Embolization System | W2-8-7 | FDA UDI | Class III | Active |
| WEB Aneurysm Embolization System | W2-8-5 | FDA UDI | Class III | Active |
| Sequel Medical | IM12300045 | FDA UDI | Class II | Active |
| Sequel Medical | IM01-0060 | FDA UDI | Class II | Active |
| Sequel Medical | IM11900075 | FDA UDI | Class II | Active |
| Sequel Medical | IM1600075 | FDA UDI | Class II | Active |
| Sequel Medical | IM12200120A | FDA UDI | Class II | Active |
| Sequel Medical | IM13200040 | FDA UDI | Class II | Active |
| WEB Aneurysm Embolization System | W4-5-S | FDA UDI | Class III | Active |
| Sequel Medical | IM01-4441 | FDA UDI | Class II | Active |
| Sequel Medical | IM13400160A | FDA UDI | Class II | Active |
| Sequel Medical | IM12220240A | FDA UDI | Class II | Active |
| WEB Aneurysm Embolization System | W2-10-6 | FDA UDI | Class III | Active |
| Sequel Medical | IM01-7003 | FDA UDI | Class II | Active |
| Sequel Medical | IM12300065 | FDA UDI | Class II | Active |
| Sequel Medical | IM50000035 | FDA UDI | Class II | Active |
| Sequel Medical | IM13300000 | FDA UDI | Class II | Active |
| Sequel Medical | IM1600003F | FDA UDI | Class II | Active |
| Sequel Medical | IM13500002 | FDA UDI | Class II | Active |
| Sequel Medical | IM11600002 | FDA UDI | Class II | Active |
| Sequel Medical | IM11000350 | FDA UDI | Class II | Active |
| Sequel Medical | IM01-2220 | FDA UDI | Class II | Active |
| Sequel Medical | 160-0001 | FDA UDI | Class II | Active |
| Sequel Medical | IM12200130A | FDA UDI | Class II | Active |
| Sequel Medical | IM01-0330 | FDA UDI | Class II | Active |
| WEB Aneurysm Embolization System | W2-11-9 | FDA UDI | Class III | Active |
| Sequel Medical | IM11700002 | FDA UDI | Class II | Active |
| WEB Aneurysm Embolization System | W4-4-S | FDA UDI | Class III | Active |
| Sequel Medical | IM01-4442 | FDA UDI | Class II | Active |
| Sequel Medical | IM01-2064 | FDA UDI | Class II | Active |
| Sequel Medical | 102-1003L | FDA UDI | Class II | Active |
| Sequel Medical | IM12600010 | FDA UDI | Class II | Active |
| WEB Aneurysm Embolization System | W4-6-6 | FDA UDI | Class III | Active |
| WEB Aneurysm Embolization System | W2-10-5 | FDA UDI | Class III | Active |
| WEB Aneurysm Embolization System | W4-6-5 | FDA UDI | Class III | Active |
| Sequel Medical | IM13400140A | FDA UDI | Class II | Active |
| WEB Aneurysm Embolization System | W2-9-7 | FDA UDI | Class III | Active |
| Sequel Medical | IM01-3031 | FDA UDI | Class II | Active |
| WEB Aneurysm Embolization System | W2-8-4 | FDA UDI | Class III | Active |
| Sequel Medical | IM14000001 | FDA UDI | Class II | Active |
| Sequel Medical | IM11000150 | FDA UDI | Class II | Active |
| Sequel Medical | IM1600003 | FDA UDI | Class II | Active |
| WEB Aneurysm Embolization System | W2-9-S | FDA UDI | Class III | Active |
| Sequel Medical | IM1600068 | FDA UDI | Class II | Active |
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 23, 2016 | Z-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. |