FDA.reportPublic FDA data

SET Rotarex™S 8 F x 110 cm

Primary DI
07640142811886
Brand
SET Rotarex™S 8 F x 110 cm
Company
Straub Medical AG
Model
80239
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
2022-05-04
Public version status
Update
Distribution status
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
K242757000

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
K242757000Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.2025-01-30MCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640142811886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142811886076401428118867640142811886

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
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
07640142810254Guidewire 0.018 4/270cm angled (Straub Medical®)Version 1.0802342020-01-31

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