FDA.reportPublic FDA data

PhenomTM 17 Catheter

Primary DI
00847536041738
Brand
PhenomTM 17 Catheter
Company
Micro Therapeutics, Inc.
Model
FG11150-0615-2X
Device description
CATHETER FG11150-0615-2X V04
Published
2019-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, percutaneous
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151638000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151638000Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc.2015-11-13DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536041738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536041738008475360417388475360417380847536041738

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight Keep Dry

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
false
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
0086001552777687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.DQY2026-10-29
07613327682427Excelsior ReachStryker CorporationDQY2026-10-29
07613327682434Excelsior ReachStryker CorporationDQY2026-10-29
07613327682441Excelsior ReachStryker CorporationDQY2026-10-29
07613327682458Excelsior ReachStryker CorporationDQY2026-10-29
07613327682465Excelsior ReachStryker CorporationDQY2026-10-29
07613327682496Excelsior ReachStryker CorporationDQY2026-10-29
07613327682526Excelsior ReachStryker CorporationDQY2026-10-29
07613327682571Excelsior ReachStryker CorporationDQY2026-10-29
00860009303423Powered Aventus Clot Management SystemInquis Medical, Inc.KRA2026-10-19
00860009303461C02 Cartridge AccessoryInquis Medical, Inc.KRA2026-10-19
00860009303492Powered Aventus Thrombectomy Catheter, 16F, 115cmInquis Medical, Inc.KRA2026-10-19
00860014559259C02 Cartridge Accessory - 5 PackInquis Medical, Inc.KRA2026-10-19
00860014559273Powered Aventus Thrombectomy CatheterInquis Medical, Inc.KRA2026-10-19
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19