Solitaire™ X-PACK

FDA UDI

Class II (US FDA UDI)

by Micro Therapeutics, Inc.

Identity

Trade Name: Solitaire™ X-PACK FDA UDI
Generic Name: Thrombectomy wire-net FDA UDI
Device Name: KIT XPACK204 V01 US FDA UDI
Model / Reference: XPACK204 FDA UDI
Description: KIT XPACK204 V01 US FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000270209 FDA UDI
510(k) Number: K091559 FDA UDI
K183022 FDA UDI
FDA Product Code: KRA FDA UDI
POL FDA UDI
NRY FDA UDI
GMDN Term: Thrombectomy wire-net FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1210 FDA UDI
882.5600 FDA UDI
870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Thrombectomy wire-net

Solitaire™ X-PACK by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thrombectomy wire-net.

ClotTriever XL Catheter — Inari Medical, Inc. · Class II
pRESET® Thrombectomy Device (4mm x 20mm) — PHENOX LIMITED · Class II
RevCore Thrombectomy Catheter — Inari Medical, Inc. · Class II
ClotTriever BOLD Catheter — Inari Medical, Inc. · Class II
pRESET® Delta LITE Thrombectomy Device (4mm x 20mm) — PHENOX LIMITED · Class II
FlowTriever Catheter, M — Inari Medical, Inc. · Class II
Laguna Clot Retriever System — Innova Vascular, Inc. · Class II
Laguna Clot Retriever System — Innova Vascular, Inc. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Micro Therapeutics, Inc.

Sources (1)

FDA UDI b5d36e6b-be50-48cb-af49-3935030cefb2 35 fields · synced May 31, 2026