SET Aspirex™ S 8F 110cm 80327

GUDID 07640142811343

The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 8F; length 110cm), one Aspirex™ Guidewire (0.018” diameter; 270cm in length), one collecting bag, and one sterile drape.

Straub Medical AG

Thrombectomy rotational catheter

• Primary Device ID: 07640142811343
• NIH Device Record Key: 28ac669b-f59a-4040-9d64-ecbabd8ad1ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SET Aspirex™ S 8F 110cm
• Version Model Number: 80327
• Catalog Number: 80327
• Company DUNS: 488489766
• Company Name: Straub Medical AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1-800-321-4254
• Email: info-straubmedical@bd.com
• Phone: +1(800)321-4254
• Email: info-straubmedical@bd.com
• Phone: +1(800)321-4254
• Email: info-straubmedical@bd.com
• Phone: +1(800)321-4254
• Email: info-straubmedical@bd.com
• Phone: +1(800)321-4254
• Email: info-straubmedical@bd.com
• Phone: +1(800)321-4254
• Email: info-straubmedical@bd.com
• Phone: +1(800)321-4254
• Email: info-straubmedical@bd.com
• Phone: +1(800)321-4254
• Email: info-straubmedical@bd.com
• Phone: +1(800)321-4254
• Email: info-straubmedical@bd.com
• Phone: +1(800)321-4254
• Email: info-straubmedical@bd.com

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 110 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640142811343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220270

FDA Product Code

• QEW: Peripheral Mechanical Thrombectomy With Aspiration

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-08
• Device Publish Date: 2022-06-30

Devices Manufactured by Straub Medical AG

• 07640142810407 - Aspirex® S 6F 110 cm: 2022-07-08 The Aspirex® S catheter (gauge 6F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlusi
• 07640142810438 - Aspirex® S 6F 135cm: 2022-07-08 The Aspirex® S catheter (gauge 6F; length 135cm) is over-the-wire, single use, percutaneous device for the treatment of occlusi
• 07640142810452 - Aspirex® S 8F 85cm: 2022-07-08 The Aspirex® S catheter (gauge 8F; length 85cm) is over-the-wire, single use, percutaneous device for the treatment of occlusio
• 07640142810483 - Aspirex® S 8F 110cm: 2022-07-08 The Aspirex® S catheter (gauge 8F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlusi
• 07640142810506 - Aspirex® S 10F 110cm: 2022-07-08 The Aspirex® S catheter (gauge 10F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlus
• 07640142810735 - Guidewire 0.025 6/270cm angled: 2022-07-08 The Rotarex™ S and Aspirex™ S Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated Tungsten tip coated
• 07640142811312 - SET Aspirex™ S 6F 110cm: 2022-07-08 The Aspirex™ S Thrombectomy Catheter Set is composed of one Aspirex™ S Thrombectomy Catheter (gauge 6F; length 110cm), one A
• 07640142811329 - SET Aspirex™ S 6F 135cm: 2022-07-08 The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 6F; length 135cm), one Aspir