DEVICE: Solitaire™ X (00847536034693)

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Device Record History
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Device Identifier (DI) Information
Solitaire™ X
SFR4-4-20-10
In Commercial Distribution

Micro Therapeutics, Inc.
00847536034693
GS1

1
826110710 *Terms of Use
STENT SFR4-4-20-10 V01 US
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61779 Thrombectomy wire-net
A device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NRY CATHETER, THROMBUS RETRIEVER
POL Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K181807 000
K183022 000
K193576 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a dry cool place
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b4419a76-b945-4ac6-ab08-226f1e8b9e6e
March 15, 2024
5
April 29, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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