HiPoint 88 reperfusion catheter with Tenzing 8 2004-88-143R

GUDID 00853799007961

HiPoint 88 reperfusion catheter with Tenzing 8; Contains Tenzing 8 delivery catheter (00853799007299) and 088 Catheter (00853799007282)

ROUTE 92 MEDICAL

Thrombectomy suction catheter

• Primary Device ID: 00853799007961
• NIH Device Record Key: bcd44d88-9e74-4dea-b24d-9a6b0c991b95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HiPoint 88 reperfusion catheter with Tenzing 8
• Version Model Number: Gen 1
• Catalog Number: 2004-88-143R
• Company DUNS: 067429673
• Company Name: ROUTE 92 MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853799007961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243601

FDA Product Code

• NRY: Catheter, Thrombus Retriever

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-05
• Device Publish Date: 2025-05-27

Devices Manufactured by ROUTE 92 MEDICAL

• 00853799007947 - HiPoint 70 reperfusion catheter with Tenzing 7: 2026-02-05 HiPoint 70 reperfusion catheter with Tenzing 7; Contains Tenzing 7 delivery catheter (00853799007541) and 070 Catheter (00853799
• 00853799007961 - HiPoint 88 reperfusion catheter with Tenzing 8: 2026-02-05HiPoint 88 reperfusion catheter with Tenzing 8; Contains Tenzing 8 delivery catheter (00853799007299) and 088 Catheter (00853799007282)
• 00853799007961 - HiPoint 88 reperfusion catheter with Tenzing 8: 2026-02-05 HiPoint 88 reperfusion catheter with Tenzing 8; Contains Tenzing 8 delivery catheter (00853799007299) and 088 Catheter (00853799
• 00853799007978 - Tenzing 7 Delivery Catheter, Single Pack: 2025-08-05 Tenzing 7 Delivery Catheter - Single Pack; Contains Tenzing 7 Delivery Catheter (00853799007541)
• 00853799007985 - Tenzing 7 Delivery Catheter, 2-pack: 2025-08-05 Tenzing 7 Delivery Catheter, 2-pack; Contains 2x of Tenzing 7 Delivery Catheter (00853799007541)
• 00853799007701 - 8F Base Camp system 2.0 80cm: 2024-10-22 8F Base Camp system 2.0 80cm
• 00853799007718 - 8F Base Camp system 2.0 80cm: 2024-10-22 8F Base Camp system 2.0 80cm; Contains 8F Base Camp system 2.0 80cm (00853799007701)
• 00853799007725 - 8F Base Camp system 2.0 90cm: 2024-10-22 8F Base Camp system 2.0 90cm
• 00853799007732 - 8F Base Camp system 2.0 90cm: 2024-10-22 8F Base Camp system 2.0 90cm; 8F Base Camp system 2.0 90cm (00853799007725)