Solitaire™

FDA UDI

Class II (US FDA UDI)

by Micro Therapeutics, Inc.

Identity

Trade Name: Solitaire™ FDA UDI
Generic Name: Thrombectomy suction catheter FDA UDI
Device Name: STENT SFR3-6-20-10 V04 US FDA UDI
Model / Reference: SFR3-6-20-10 FDA UDI
Description: STENT SFR3-6-20-10 V04 US FDA UDI

Identifiers

Primary DI / UDI-DI: 00847536033955 FDA UDI
510(k) Number: K153071 FDA UDI
FDA Product Code: NRY FDA UDI
GMDN Term: Thrombectomy suction catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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 suction catheter

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

Similar devices

Also classified as Thrombectomy suction catheter.

Symphony™ ProHelix™ — IMPERATIVE CARE INC. · Class II
Prodigy™ Catheter — IMPERATIVE CARE INC. · Class II
Symphony™ Advance™ Long Dilator — IMPERATIVE CARE INC. · Class II
Indigo System — PENUMBRA, INC. · Class II
Penumbra System — PENUMBRA, INC. · Class II
Trevo — Stryker Corp.
Penumbra System — PENUMBRA, INC. · Class II
Pounce ™ Thrombectomy — Surmodics, Inc. · Class II

Cleared under the same submission

K153071 also covers:

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 205ae05d-a9d8-484f-9d05-7d665e6c714d 36 fields · synced May 31, 2026