FDA.reportPublic FDA data

Solitaire™ X-PACK

Primary DI
00763000270162
Brand
Solitaire™ X-PACK
Company
Micro Therapeutics, Inc.
Model
XPACK200
Device description
KIT XPACK200 V01 US
Published
2019-11-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091559000
K183022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091559000MARKSMANN CATHETERChestnut Medical Technologies, Inc.2009-09-18KRA
K183022000Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-01-29POL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000270162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000270162007630002701627630002701620763000270162

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 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.

Contacts#

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

Regulatory Flags#

DUNS number
826110710
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391539370296Millipede88 CatheterPERFUZE LIMITEDNRY2026-08-21
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00818075011209SocratesSCIENTIA VASCULAR LLCNRY2025-05-27
00818075011216SocratesSCIENTIA VASCULAR LLCNRY2025-05-27
00853799007541Tenzing 7 Delivery CatheterROUTE 92 MEDICALNRY2024-05-16
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00853799007619Tenzing 5 delivery catheterROUTE 92 MEDICALNRY2023-10-16
00812212030573Zoom 88 Large Distal Platform SupportIMPERATIVE CARE, INC.NRY2023-06-02
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
07613327519358AXS VECTA 46Stryker CorporationNRY2021-12-17
07613327519365AXS VECTA 46Stryker CorporationNRY2021-12-17
07613327519372AXS VECTA 46Stryker CorporationNRY2021-12-17
07613327519389AXS VECTA 46Stryker CorporationNRY2021-12-17
07640132622690M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01
00812212030337TracStar LDP Large Distal PlatformIMPERATIVE CARE, INC.NRY2021-09-22
00812212030344TracStar LDP Large Distal PlatformIMPERATIVE CARE, INC.NRY2021-09-22
00812212030368Zoom 88 Large Distal PlatformIMPERATIVE CARE, INC.NRY2021-09-22
00763000399641PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399658PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399665PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399672PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399689PhenomTM 21 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399702PhenomTM 27 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399719PhenomTM 27 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399733PhenomTM Plus CatheterMicro Therapeutics, Inc.KRA2021-04-26
00847536041967REACT™Micro Therapeutics, Inc.NRY2021-03-18
00847536044197REACT™Micro Therapeutics, Inc.NRY2021-03-18