FDA.reportPublic FDA data

Solitaire™ X-PACK

Primary DI
00763000270810
Brand
Solitaire™ X-PACK
Company
Micro Therapeutics, Inc.
Model
XPACK347
Device description
KIT XPACK347 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
00763000270810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000270810007630002708107630002708100763000270810

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
00199150045532OnyxTM Liquid Embolic System (LES)105-7100-0602026-06-07
00763000488017Axium™ Detachable Coil SystemQC-2.5-4-HELIX2022-10-28
00763000488192Axium™ Detachable Coil SystemQC-10-20-HELIX2022-10-28
00763000488239Axium™ Detachable Coil SystemQC-14-30-HELIX2022-10-28
00763000488260Axium™ Detachable Coil SystemQC-16-40-HELIX2022-10-28
00763000488727Axium™ Detachable Coil SystemQC-25-50-3D2022-10-28
00763000488796Axium™ Detachable Coil SystemNC-3-4-HELIX2022-10-28
00763000488826Axium™ Detachable Coil SystemNC-4-8-HELIX2022-10-28
00763000488864Axium™ Detachable Coil SystemPC-2-3-HELIX2022-10-28
00763000488932Axium™ Detachable Coil SystemPC-4-8-HELIX2022-10-28
00763000488994Axium™ Detachable Coil SystemPC-7-20-HELIX2022-10-28
00763000489052Axium™ Detachable Coil SystemPC-10-20-HELIX2022-10-28
00763000489076Axium™ Detachable Coil SystemPC-2-2-3D2022-10-28
00763000489137Axium™ Detachable Coil SystemPC-4-6-3D2022-10-28
00847536032866AxiumTMNC-2-6-HELIX2019-06-29
00847536033306AxiumTMPC-6-15-3D2019-06-29
00847536033368AxiumTMPC-8-20-3D2019-06-29
00847536029668AxiumTMQC-8-30-HELIX2019-06-20
00847536029729AxiumTMQC-12-40-HELIX2019-06-20
00847536029781AxiumTMQC-20-40-HELIX2019-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000539351RebarMicro Therapeutics, Inc.KRA2022-02-27
00763000425272Solitaire ™ PlatinumMicro Therapeutics, Inc.NRY2021-03-12
00763000425272Solitaire ™ PlatinumMicro Therapeutics, Inc.POL2021-03-12
00763000425333Solitaire ™ PlatinumMicro Therapeutics, Inc.POL2021-03-12
00763000425333Solitaire ™ PlatinumMicro Therapeutics, Inc.NRY2021-03-12
00763000425395Solitaire ™ PlatinumMicro Therapeutics, Inc.NRY2021-03-12
00763000425395Solitaire ™ PlatinumMicro Therapeutics, Inc.POL2021-03-12
00763000425456Solitaire ™ PlatinumMicro Therapeutics, Inc.NRY2021-03-12
00763000425456Solitaire ™ PlatinumMicro Therapeutics, Inc.POL2021-03-12
00763000425579Solitaire ™ PlatinumMicro Therapeutics, Inc.NRY2021-03-12
00763000425579Solitaire ™ PlatinumMicro Therapeutics, Inc.POL2021-03-12
00763000270162Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270162Solitaire™ X-PACKMicro Therapeutics, Inc.KRA2019-11-08
00763000270162Solitaire™ X-PACKMicro Therapeutics, Inc.POL2019-11-08
00763000270179Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270179Solitaire™ X-PACKMicro Therapeutics, Inc.KRA2019-11-08
00763000270179Solitaire™ X-PACKMicro Therapeutics, Inc.POL2019-11-08
00763000270186Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270186Solitaire™ X-PACKMicro Therapeutics, Inc.POL2019-11-08
00763000270186Solitaire™ X-PACKMicro Therapeutics, Inc.KRA2019-11-08
00763000270193Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270193Solitaire™ X-PACKMicro Therapeutics, Inc.POL2019-11-08
00763000270193Solitaire™ X-PACKMicro Therapeutics, Inc.KRA2019-11-08
00763000270209Solitaire™ X-PACKMicro Therapeutics, Inc.POL2019-11-08
00763000270209Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270209Solitaire™ X-PACKMicro Therapeutics, Inc.KRA2019-11-08
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.NRY2019-11-08
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.POL2019-11-08
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.KRA2019-11-08