FDA.reportPublic FDA data

MicroMewiTM

Primary DI
00847536008014
Brand
MicroMewiTM
Company
Micro Therapeutics, Inc.
Model
41063-01
Device description
INF CATH 41063-01 MICROMEWI V03
Published
2016-04-01
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
00847536008014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536008014008475360080148475360080140847536008014

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
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

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
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
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007147SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007154SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007161SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007178SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007185SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007192SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007208SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007215SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007222SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007239SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007246SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007253SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007260SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007277SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007284SOL CARE 1 DELTA MED SPAFOZ2021-03-30
08032248007291SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248005372Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005389Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005396Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005402Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005419Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005426Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005433Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005440Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005457Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005464Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005471Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005495Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26