FDA.reportPublic FDA data

HiPoint 88 reperfusion catheter with Tenzing 8

Primary DI
00853799007961
Brand
HiPoint 88 reperfusion catheter with Tenzing 8
Company
ROUTE 92 MEDICAL
Model
Gen 1
Catalog number
2004-88-143R
Device description
HiPoint 88 reperfusion catheter with Tenzing 8; Contains Tenzing 8 delivery catheter (00853799007299) and 088 Catheter (00853799007282)
Published
2025-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRYCatheter, Thrombus Retriever

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243601000Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.2025-05-19NRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853799007961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853799007961008537990079618537990079610853799007961

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-350-9416Customerservice@r92m.com

Regulatory Flags#

DUNS number
067429673
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
008537990079308F Base Camp System 2.0 90cmGen 2.05001-2-90B2026-07-08
008537990077018F Base Camp system 2.0 80cmGen 2.05001-2-80B2024-10-14
008537990077188F Base Camp system 2.0 80cmGen 2.05001-2-80B2024-10-14
008537990077258F Base Camp system 2.0 90cmGen 2.05001-2-90B2024-10-14
008537990077328F Base Camp system 2.0 90cmGen 2.05001-2-90B2024-10-14
00853799007749FreeClimb 88 catheter, 125cmGen 12024-07-01
00853799007756FreeClimb 88 catheter, 132cmGen 12024-07-01
00853799007763FreeClimb 88 catheter, 125cm with Tenzing 8Gen 17001-88-1252024-07-01
00853799007770FreeClimb 88 catheter, 132cm with Tenzing 8Gen 17001-88-1322024-07-01
00853799007442070 Access SystemGen 1REF 10042024-05-17
00853799007459070 CatheterGen 12024-05-17
00853799007077088 x 125 cm Full Length CatheterGen 12024-05-16
00853799007145088 x 125 cm Full Length Access SystemGen 1REF 40042024-05-16
008537990074118F Base Camp Sheath SystemGen 1.550012024-05-16
00853799007541Tenzing 7 Delivery CatheterGen 12024-05-16
00853799007626FreeClimb 54 x 148 cm CatheterGen 12023-10-16
00853799007633FreeClimb 54 x 125 cm CatheterGen 12023-10-16
00853799007619Tenzing 5 delivery catheterGen 12023-10-16
00853799007640FreeClimb 54 x 148 cm Access SystemGen 1REF 60022024-05-16
00853799007657FreeClimb 54 x 125 cm Access SystemGen 1REF 60042024-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391539370296Millipede88 CatheterPERFUZE LIMITEDNRY2026-08-21
00857545008295Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008301Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008318Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008325Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008332Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00763000974077Riptide™Micro Therapeutics, Inc.NRY2026-03-30
00850083646004NeVasc .070 Aspiration Catheter, 115 cmVesalioNRY2026-03-26
00851279008972NeVasc .070 Aspiration Catheter, 140 cmVesalioNRY2026-03-26
00851279008989NeVasc .070 Aspiration Catheter, 132 cmVesalioNRY2026-03-26
00851279008996NeVasc .070 Aspiration Catheter, 125 cmVesalioNRY2026-03-26
00850014025182APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025199APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025205APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025212APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
07290015107341Tigertriever 25 Revascularization DeviceRAPID MEDICAL LTDNRY2026-03-16
00763000950750Riptide™ Aspiration PumpMicro Therapeutics, Inc.NRY2026-03-09
05391530910231Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
05391530910248Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
00763000974091Riptide™Micro Therapeutics, Inc.NRY2025-12-13
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
07290015107402Tigertriever 17 Ultra Revascularization DeviceRAPID MEDICAL LTDNRY2025-11-17
10886704088097CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088103CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088110CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088141CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704086437CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086451CEREGLIDECerenovus, Inc.NRY2025-09-26