FDA.reportPublic FDA data

SET Rotarex®S 8F 110 cm (Straub Medical®)

Primary DI
07640142810605
Brand
SET Rotarex®S 8F 110 cm (Straub Medical®)
Company
Straub Medical AG
Model
Version 1.0
Catalog number
80239
Device description
Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.
Published
2020-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
MCWCatheter, Peripheral, Atherectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
MCWCatheter, Peripheral, AtherectomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172315000
K211738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172315000Straub Endovascular SystemStraub Medical AG2018-04-12MCW
K211738000Rotarex Atherectomy SystemC.R. Bard, Inc.2021-09-14MCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640142810605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142810605076401428106057640142810605

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system catheter/handpieceA sterile catheter with attached handpiece, with a power-driven cutting or abrasive head intended to mechanically disrupt/remove atheroma plaque from the walls of both coronary and peripheral arteries. The operator regulates the energy via a remote control or foot-switch attached to the generator. The handpiece may also serve as a conduit for irrigation, aspiration and placement of a guidewire during surgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Catheter Working Length110Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41817200460info@straubmedical.com
+1-800-321-4254info-straubmedical@bd.com

Regulatory Flags#

DUNS number
488489766
Device count
1
Kit
true
Lot or batch
true
Expiration 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
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
07290017590264AuryonEXIMO MEDICAL LTDMCW2026-06-02
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07290017590325Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
07290017590332Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
07290017590288Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2023-12-28
07290017590295Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2023-12-28
07290017590301Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2023-12-28
07290017590318Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2023-12-28
07290017590141Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2022-10-04
07290017590158Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2022-10-04
07290017590165Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2022-10-04
07290017590172Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2022-10-04
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
10193489078022NAMICMEDLINE INDUSTRIES, INC.DQX2022-02-24
30193489067044NAMICMEDLINE INDUSTRIES, INC.DQX2021-06-03
07613327508499Synchro SELECTStryker CorporationDQX2020-10-20
07613327508512Synchro SELECTStryker CorporationDQX2020-10-20
07613327508529Synchro SELECTStryker CorporationDQX2020-10-20
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