HiPoint 88 reperfusion catheter with Tenzing 8

FDA UDI

Class II (US FDA UDI)

by Route 92 Medical, Inc.

Identity

Trade Name: HiPoint 88 reperfusion catheter with Tenzing 8 FDA UDI
Generic Name: Thrombectomy suction catheter FDA UDI
Device Name: HiPoint 88 reperfusion catheter with Tenzing 8; Contains Tenzing 8 delivery catheter (00853799007299) and 088 Catheter (00853799007282) FDA UDI
Model / Reference: Gen 1 FDA UDI
Description: HiPoint 88 reperfusion catheter with Tenzing 8; Contains Tenzing 8 delivery catheter (00853799007299) and 088 Catheter (00853799007282) FDA UDI

Identifiers

Catalog Number: REF 2004-88-143R FDA UDI
Primary DI / UDI-DI: 00853799007961 FDA UDI
510(k) Number: K243601 FDA UDI
FDA Product Code: NRY FDA UDI
GMDN Term: Thrombectomy suction catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Thrombectomy suction catheter

HiPoint 88 reperfusion catheter with Tenzing 8 by Route 92 Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K243601 also covers:

HiPoint 70 reperfusion catheter with Tenzing 7 — Route 92 Medical, Inc.

Manufacturer's product page: HiPoint® Reperfusion System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Route 92 Medical, Inc.

Sources (1)

FDA UDI bcd44d88-9e74-4dea-b24d-9a6b0c991b95 36 fields · synced May 30, 2026