Question 1

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

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Sequel Medical	IM60000020	FDA UDI	Class II	Active
Sequel Medical	IM15000002	FDA UDI	Class II	Active
Sequel Medical	IM01-2062	FDA UDI	Class II	Active
Sequel Medical	IM12500016	FDA UDI	Class II	Active
Sequel Medical	IM11700004	FDA UDI	Class II	Active
WEB Aneurysm Embolization System	W2-10-S	FDA UDI	Class III	Active
Sequel Medical	IM12400020	FDA UDI	Class II	Active
Sequel Medical	IM01-4444	FDA UDI	Class II	Active
Sequel Medical	160-0002	FDA UDI	Class II	Active
Sequel Medical	IM1600002	FDA UDI	Class II	Active
Sequel Medical	IM11800190	FDA UDI	Class II	Active
WEB Aneurysm Embolization System	W4-7-6	FDA UDI	Class III	Active
WEB Aneurysm Embolization System	W2-8-6	FDA UDI	Class III	Active
Sequel Medical	IM12000160A	FDA UDI	Class II	Active
WEB Aneurysm Embolization System	W2-11-7	FDA UDI	Class III	Active
WEB Aneurysm Embolization System	W2-11-8	FDA UDI	Class III	Active
WEB Aneurysm Embolization System	W2-9-6	FDA UDI	Class III	Active
WEB Aneurysm Embolization System	W2-10-7	FDA UDI	Class III	Active
WEB Aneurysm Embolization System	W4-7-3	FDA UDI	Class III	Active
Via Microcatheter, Via Plus Microcatheter	K123477	FDA 510(k)	Class II	Active
VIA 17 Microcatheter	K162565	FDA 510(k)	Class II	Active
Via Microcatheter, Via Plus Microcatheter	K132652	FDA 510(k)	Class II	Active
Sequel External Fixation Device	K202833	FDA 510(k)	Class II	Active
VIA 21 Microcatheter	K150894	FDA 510(k)	Class II	Active

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