FDA.reportPublic FDA data

Drive System (Straub Medical®)

Primary DI
07640142810889
Brand
Drive System (Straub Medical®)
Company
Straub Medical AG
Model
Version 1.0
Catalog number
80300
Device description
The Drive System consists of three components; the control unit, motor (with cable) and footswitch (with cable).
Published
2020-01-31
Public version status
Update
Distribution status
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
07640142810889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142810889076401428108897640142810889

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity070 Percent (%) Relative Humidity
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4181720046info@straubmedical.com
+1-800-321-4254info-straubmedical@bd.com
+1(800)321-4254info-straubmedical@bd.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

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Primary DI, Brand, Company table
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