FDA.reportPublic FDA data

MarksmanTM

Primary DI
00847536008335
Brand
MarksmanTM
Company
Micro Therapeutics, Inc.
Model
FA-55160-1030
Device description
FA-55160-1030 MARKSMAN CATHETER 160CM
Published
2016-04-03
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091559000MARKSMANN CATHETERChestnut Medical Technologies, Inc.2009-09-18KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536008335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536008335008475360083358475360083350847536008335

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid temperature extremes, keep dry, keep away from sunlight

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
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
true

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
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
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
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
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.KRA2025-04-09
00810123710577Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-11
00810123710560Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-07
B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00810123710140ClotTriever CatheterInari Medical, Inc.KRA2024-04-17
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.KRA2024-03-27
00810123710430ClotTriever SheathInari Medical, Inc.KRA2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00850291007369InThrill SheathInari Medical, Inc.KRA2023-07-18
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007376Artix AXInari Medical, Inc.KRA2023-04-24
00850291007222Protrieve SheathInari Medical, Inc.KRA2023-03-20
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22