FDA.reportPublic FDA data

Control Unit (with cord) (Straub Medical®)

Primary DI
07640142810872
Brand
Control Unit (with cord) (Straub Medical®)
Company
Straub Medical AG
Model
Version 1.0
Catalog number
80301
Device description
The control unit console contains the power supply, system controller, mode selectors, and has auditory and visual alarms to signify irregularities in the rotational speed. The control unit is designed for tabletop use outside the sterile field. The control unit is a part of the Straub Medical Drive System.
Published
2020-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCWCatheter, Peripheral, Atherectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCWCatheter, Peripheral, AtherectomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172315000Straub Endovascular SystemStraub Medical AG2018-04-12MCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640142810872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142810872076401428108727640142810872

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy/thrombectomy drive systemA multi-purpose assembly of devices designed to power and control the mechanical mechanism of an atherectomy catheter and, alternatively, a thrombectomy catheter during an intravascular recanalization procedure. It typically consists of a mains electricity (AC-powered) control unit that supplies the drive motor with low-voltage electricity (e.g., 24 volt) to power the magnetic power transmission for the mechanical mechanism of the catheter, a pistol-like handpiece with hand-switch including the drive motor (for catheter manipulation), and a foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41817200460info@straubmedical.com

Regulatory Flags#

DUNS number
488489766
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640142811305Guidewire 0.025 6/270cm angled 80265802652022-06-30
07640142810407Aspirex® S 6F 110 cm 80209802092022-06-30
07640142810438Aspirex® S 6F 135cm 80203802032022-06-30
07640142810452Aspirex® S 8F 85cm 80210802102022-06-30
07640142810483Aspirex® S 8F 110cm 80204802042022-06-30
07640142810506Aspirex® S 10F 110cm 80211802112022-06-30
07640142811817Rotarex™S 6 F x 110 cm 80332803322022-05-04
07640142811824Rotarex™S 6 F x 135 cm80333803332022-05-04
07640142811831Rotarex™S 8 F x 85 cm80334803342022-05-04
07640142811848Rotarex™S 8 F x 110 cm 80335803352022-05-04
07640142811855SET Rotarex™S 6 F x 110 cm80236802362022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm 80237802372022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm 80238802382022-05-04
07640142811886SET Rotarex™S 8 F x 110 cm80239802392022-05-04
07640142810278Rotarex®S 6F 110cm (Straub Medical®)Version 1.0802082020-02-07
07640142810292Rotarex®S 6F 135cm (Straub Medical®)Version 1.0802012020-02-07
07640142810353Rotarex®S 8F 85cm (Straub Medical®)Version 1.0802062020-02-07
07640142810384Rotarex®S 8F 110cm (Straub Medical®)Version 1.0802072020-02-07
07640142810193Drape, sterile for motor or footswitch (Straub Medical®)Version 1.0800682020-01-31
07640142810247Guidewire 0.018 4/220cm angled (Straub Medical®)Version 1.0802332020-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017590264AuryonEXIMO MEDICAL LTDMCW2026-06-02
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183865PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
00857141005322Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005339Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005346Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005377Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005384Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005391Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005407Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005414Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00810060550793Turbo-Power Laser Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2025-10-21
00810060550809Turbo-Power Laser Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2025-10-21
00763000835392HawkOne™MEDTRONIC, INC.MCW2024-12-28
07290017590325Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
07290017590332Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
00763000918934TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918941TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918958TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918910SilverHawk™MEDTRONIC, INC.MCW2024-08-10
00763000918927SilverHawk™MEDTRONIC, INC.MCW2024-08-10
00763000918965Cutter DriverMEDTRONIC, INC.MCW2024-08-10
00845225003463Phoenix 1.5mm x 149cm 4F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003470Phoenix 1.8mm x 130cm 5F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003487Phoenix 1.8mm x 149cm 5F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003494Phoenix 2.2mm x 130cm 6F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003500Phoenix 2.2mm x 149cm 6F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003517Phoenix 2.2mm x 130cm 6F Pre-Deflected Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08