← Back to catalogue
HiPoint 70 reperfusion catheter with Tenzing 7
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- HiPoint 70 reperfusion catheter with Tenzing 7 FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- HiPoint 70 reperfusion catheter with Tenzing 7; Contains Tenzing 7 delivery catheter (00853799007541) and 070 Catheter (00853799007459) FDA UDI
- Model / Reference
- Gen 1 FDA UDI
- Description
- HiPoint 70 reperfusion catheter with Tenzing 7; Contains Tenzing 7 delivery catheter (00853799007541) and 070 Catheter (00853799007459) FDA UDI
Identifiers
- Catalog Number
- REF 2004-70-142R FDA UDI
- Primary DI / UDI-DI
- 00853799007947 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thrombectomy suction catheter
HiPoint 70 reperfusion catheter with Tenzing 7 by Route 92 Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy suction catheter.
- Symphony™ ProHelix™ — IMPERATIVE CARE INC. · Class II
- Prodigy™ Catheter — IMPERATIVE CARE INC. · Class II
- Symphony™ Advance™ Long Dilator — IMPERATIVE CARE INC. · Class II
- Indigo System — PENUMBRA, INC. · Class II
- Penumbra System — PENUMBRA, INC. · Class II
- Trevo — Stryker Corp.
- Penumbra System — PENUMBRA, INC. · Class II
- Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
Cleared under the same submission
K243601 also covers:
Manufacturer's product page: HiPoint® Reperfusion System
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Route 92 Medical, Inc.
Sources (2)
- FDA UDI 1eb714aa-4530-4056-a78d-c6adcab07b61 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026