FDA.reportPublic FDA data

Cragg-McNamaraTM

Primary DI
00847536006706
Brand
Cragg-McNamaraTM
Company
Micro Therapeutics, Inc.
Model
41040-01
Device description
INF CATH 41040-01 CRAGG-MCNAMARA V04
Published
2016-09-18
Public version status
Update
Distribution status
Not 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
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940634000MICRO THERAPEUTICS INFUSION CATHETERMicro Therapeutics, Inc.1994-10-14FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536006706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536006706008475360067068475360067060847536006706

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor microcatheter for access into superselective small vessels. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight, keep dry, avoid extreme temperatures

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
826110710
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847536041950PhenomTM Plus CatheterFG19135-1030-1S2019-04-22
00847536005648HyperGlideTM104-45202016-04-03
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

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Primary DI, Brand, Company table
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00382903935352NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
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00382903935376NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
10801902167344ARROWTELEFLEX INCORPORATEDFOZ2026-07-30
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10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
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10884521832930MAHURKARMozarc Medical US LLCFOZ2022-11-03
10884521832985MAHURKARMozarc Medical US LLCFOZ2022-11-03
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