FDA.reportPublic FDA data

Rist™

Primary DI
00763000413804
Brand
Rist™
Company
Micro Therapeutics, Inc.
Model
105F-BER-130
Device description
CATH RADIAL DX 105F-BER-130 V01 US
Published
2020-10-05
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
DQOCatheter, intravascular, diagnostic
DQYCatheter, percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200417000
K201682000
K241388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200417000RIST Radial Access CatheterRist Neurovascular, Inc.2020-05-02QJP
K201682000RIST Radial Access CatheterRist Neurovascular, Inc.2020-09-28QJP
K241388000Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2025-01-02QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000413804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000413804007630004138047630004138040763000413804

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.

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
DM exempt
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
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07613327623352AXS LiftStryker CorporationQJP2025-03-04
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07613327623390AXS LiftStryker CorporationQJP2025-03-04
07613327519372AXS VECTA 46Stryker CorporationQJP2021-12-17
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
07613327313956Trevo Trak 21Stryker CorporationQJP2020-04-17
07613327417203AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327417227AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327459241AXS VECTA 74Stryker CorporationQJP2019-02-19
07613327459258AXS VECTA 74Stryker CorporationQJP2019-02-19
07613327459265AXS VECTA 74Stryker CorporationQJP2019-02-19
07613327459210AXS VECTA 71Stryker CorporationQJP2018-10-26
07613327459227AXS VECTA 71Stryker CorporationQJP2018-10-26
07613327459234AXS VECTA 71Stryker CorporationQJP2018-10-26
07613327313888DAC 038Stryker CorporationDQY2016-09-21
07613327313895DAC 038Stryker CorporationDQO2016-09-21
07613327313901DAC 057Stryker CorporationDQY2016-09-21
07613327313918DAC 044Stryker CorporationDQO2016-09-21
07613327313925DAC 044Stryker CorporationDQO2016-09-21
07613327313932DAC 070Stryker CorporationDQY2016-09-21
07613327313949DAC 057Stryker CorporationDQY2016-09-21
07613327313963DAC 070Stryker CorporationDQO2016-09-21
07613327313987DAC 044Stryker CorporationDQO2016-09-21
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