FDA.reportPublic FDA data

Solitaire™ X

Primary DI
00763000425654
Brand
Solitaire™ X
Company
Micro Therapeutics, Inc.
Model
SFR4-4-20-10
Device description
STENT SFR4-4-20-10 V03 SOLITIARE4
Published
2020-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRYCATHETER, THROMBUS RETRIEVER
POLNeurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2
POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke TreatmentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183022000
K193576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183022000Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-01-29POL
K193576000Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2020-11-20POL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000425654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000425654007630004256547630004256540763000425654

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, cool place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
826110710
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847536003446Echelon103-50952015-10-23
00763000541194RistTM106F-071-952022-05-01
00763000541200RistTM106F-071-1002022-05-01
00763000541217RistTM106F-071-1052022-05-01
00763000413767Rist™107F-079-952020-10-05
00763000413774Rist™107F-079-1002020-10-05
00763000413781Rist™107F-079-1052020-10-05
00763000413798Rist™105F-BER-1202020-10-05
00763000413804Rist™105F-BER-1302020-10-05
00763000413811Rist™105F-SIM-1202020-10-05
00763000413828Rist™105F-SIM-1302020-10-05
00763000399641PhenomTM 17 CatheterFG11150-0615-2J2021-04-26
00763000399658PhenomTM 17 CatheterFG11150-0615-2R2021-04-26
00763000399665PhenomTM 17 CatheterFG11150-0615-2S2021-04-26
00763000399672PhenomTM 17 CatheterFG11150-0615-2X2021-04-26
00763000399689PhenomTM 21 CatheterFG13150-0615-2S2021-04-26
00763000399702PhenomTM 27 CatheterFG15150-0615-1S2021-04-26
00763000399719PhenomTM 27 CatheterFG15150-0630-1S2021-04-26
00763000399733PhenomTM Plus CatheterFG19120-1030-1S2021-04-26
00847536041967REACT™REACT-682021-03-18

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00818075011209SocratesSCIENTIA VASCULAR LLCNRY2025-05-27
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00853799007541Tenzing 7 Delivery CatheterROUTE 92 MEDICALNRY2024-05-16
00853799007619Tenzing 5 delivery catheterROUTE 92 MEDICALNRY2023-10-16
10886704085355CEREGLIDECerenovus, Inc.NRY2023-07-07
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00812212030573Zoom 88 Large Distal Platform SupportIMPERATIVE CARE, INC.NRY2023-06-02
00810170018831ERIC Retrieval DeviceMicrovention, Inc.NRY2022-10-12
00810170018848ERIC Retrieval DeviceMicrovention, Inc.NRY2022-10-12