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SolitaireTM

FDA UDI

Class II (US FDA UDI)

by Micro Therapeutics, Inc.

Identity

Trade Name
SolitaireTM FDA UDI
Generic Name
Thrombectomy suction catheter FDA UDI
Device Name
STENT SFR3-4-20-10V01 US FDA UDI
Model / Reference
SFR3-4-20-10 FDA UDI
Description
STENT SFR3-4-20-10V01 US FDA UDI

Identifiers

Primary DI / UDI-DI
00847536020528 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Thrombectomy suction catheter

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

Similar devices

Also classified as Thrombectomy suction catheter.

Cleared under the same submission

K153071 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro Therapeutics, Inc.

Sources (1)

  • FDA UDI 580b85e2-163e-4069-9d06-8f89ab540bef 36 fields · synced May 31, 2026