FDA.reportPublic FDA data

Solitaire™ X-PACK

Primary DI
00763000270803
Brand
Solitaire™ X-PACK
Company
Micro Therapeutics, Inc.
Model
XPACK346
Device description
KIT XPACK346 V01 US
Published
2019-11-07
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
DQYCatheter, percutaneous
KRACatheter, continuous flush
NRYCATHETER, THROMBUS RETRIEVER
POLNeurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
KRACatheter, Continuous FlushCardiovascular2
NRYCatheter, Thrombus RetrieverCardiovascular2
POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke TreatmentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180959000
K182097000
K183022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180959000Phenom 27 CatheterCathera, Inc.2018-06-11DQY
K182097000React 71 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2018-11-14DQY
K183022000Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-01-29POL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000270803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000270803007630002708037630002708030763000270803

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy wire-netA device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter (not included) for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction. Also referred to as a stent retriever, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; in some cases revascularization may be achieved through thrombus reorientation. This is a single-use device.

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
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000974077Riptide™MAT-110-1102026-03-30
00763000290702Instant DetacherID-1-52023-01-30
00763000950750Riptide™ Aspiration PumpMAP-10002026-03-09
00763000491772Avyon™ 8FR Balloon Guide Catheter8F-087-85CM2021-04-15
00763000491789Avyon™ 8FR Balloon Guide Catheter8F-087-95CM2021-04-15
00763000915681Riptide™ Aspiration PumpLMT-RAP2025-08-18
00763000925338OnyxTM Liquid Embolic System (LES)105-7100-0602026-01-02
00763000925352OnyxTM Liquid Embolic System (LES)105-7100-0802026-01-02
00847536026834RebarTM105-5081-1532017-04-14
00763000974091Riptide™MAC-12002025-12-13
00763000294236HyperForm104-44202020-08-01
00763000294298HyperForm104-47152020-08-01
00836462002180RebarTM105-5081-1302015-10-09
00847536005471HyperFormTM104-44202016-08-19
00847536005549HyperFormTM104-44702016-04-05
00847536005792HyperFormTM104-47152016-08-14
00836462002197Rebar105-5081-1532015-10-22
00763000294267HyperForm104-44702020-08-01
00763000294328HyperForm104-47702020-08-01
00836462002135Rebar105-5080-1532015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327519358AXS VECTA 46Stryker CorporationNRY2021-12-17
07613327519365AXS VECTA 46Stryker CorporationNRY2021-12-17
07613327519389AXS VECTA 46Stryker CorporationNRY2021-12-17
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07613327299922Trevo NXTStryker CorporationPOL2020-04-20
07613327299939Trevo NXTStryker CorporationPOL2020-04-20
07613327299946Trevo NXTStryker CorporationNRY2020-04-20
07613327299953Trevo NXTStryker CorporationPOL2020-04-20
07613327417203AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327417210AXS Catalyst 7Stryker CorporationNRY2019-05-13
07613327417227AXS Catalyst 7Stryker CorporationDQY2019-05-13
07640132622157M-CATH MicrocatheterAcrostak (Schweiz) AGKRA2018-05-15
07613327011999AXS Catalyst 5Stryker CorporationNRY2016-09-21
07613327012019AXS Catalyst 5Stryker CorporationNRY2016-09-21
07613327012033AXS Catalyst 6Stryker CorporationNRY2016-09-21
07613327313888DAC 038Stryker CorporationDQY2016-09-21
07613327313901DAC 057Stryker CorporationDQY2016-09-21
07613327313932DAC 070Stryker CorporationDQY2016-09-21
07613327313949DAC 057Stryker CorporationDQY2016-09-21
08033477048772REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048802REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048833REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048864REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048888REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048925REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048956REEF HPMEDTRONIC, INC.DQY2016-06-19