FDA.reportPublic FDA data

FreeClimb 54 x 148 cm Access System

Primary DI
00853799007640
Brand
FreeClimb 54 x 148 cm Access System
Company
ROUTE 92 MEDICAL
Model
Gen 1
Catalog number
REF 6002
Device description
FreeClimb 54 x 148 cm Access System: Contains Tenzing 5 delivery catheter (00853799007619) and FreeClimb 54 x 148 cm Catheter (00853799007626)
Published
2024-05-16
Public version status
Update
Distribution status
Not 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
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231583000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231583000Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc.2023-08-15QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853799007640PackageGS11In Commercial Distribution
00853799007626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853799007640008537990076408537990076400853799007640
00853799007626008537990076268537990076260853799007626

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
00853799007497FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7Gen 17001-70-132R2024-05-16
00853799007947HiPoint 70 reperfusion catheter with Tenzing 7Gen 12004-70-142R2025-05-27
00853799007961HiPoint 88 reperfusion catheter with Tenzing 8Gen 12004-88-143R2025-05-27
00853799007978Tenzing 7 Delivery Catheter, Single PackGen 17001-T71-1512025-07-28
00853799007985Tenzing 7 Delivery Catheter, 2-packGen 17001-T72-1512025-07-28
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
00853799007763FreeClimb 88 catheter, 125cm with Tenzing 8Gen 17001-88-1252024-07-01
00853799007770FreeClimb 88 catheter, 132cm with Tenzing 8Gen 17001-88-1322024-07-01
00853799007688FreeClimb 54 reperfusion catheter, 148cm with Tenzing 5Gen 17001-54-148R2024-05-30
00853799007695FreeClimb 54 reperfusion catheter, 125cm with Tenzing 5Gen 17001-54-125R2024-05-30
008537990074118F Base Camp Sheath SystemGen 1.550012024-05-16
00853799007534Tenzing 7 Delivery CatheterGen 110052024-05-16
00853799007275088 Access SystemGen 120042020-09-18
008537990074048F Base Camp Sheath SystemGen 1.550012020-09-17
00853799007077088 x 125 cm Full Length CatheterGen 12024-05-16
00853799007145088 x 125 cm Full Length Access SystemGen 1REF 40042024-05-16
00853799007626FreeClimb 54 x 148 cm CatheterGen 12023-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04544050121057CELLO II Balloon Guide Catheter, 8F 90cmFUJI SYSTEMS CORPORATIONQJP2026-05-25
0086001552770787 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-05-18
0086001552771487 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-05-18
06970908212079Paragon 8F Balloon Guide CatheteShanghai Wallaby Medical Technologies Co., Inc.QJP2026-04-15
06970908212086Paragon 8F Balloon Guide CatheteShanghai Wallaby Medical Technologies Co., Inc.QJP2026-04-15
00850014025397APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025403APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025410APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025427APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
05391539370197Millipede 088 Access CatheterPERFUZE LIMITEDQJP2026-03-24
00810201980007SurfRider 13 MicrocatheterKANEKA AMERICAS HOLDING INCQJP2026-02-17
00810201980014SurfRider 13 MicrocatheterKANEKA AMERICAS HOLDING INCQJP2026-02-17
00850074235101Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-16
0086001030636987 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
0086001030637687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
00860013060619Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-02
00840303713128Carrier XL Delivery CatheterBALT USA LLCQJP2025-10-24
00840303713135Carrier XL Delivery CatheterBALT USA LLCQJP2025-10-24
00840303713470Carrier XL Delivery CatheterBALT USA LLCQJP2025-10-24
10886704088097CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088103CEREGLIDECerenovus, Inc.QJP2025-10-13
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10886704086512CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086536CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086550CEREGLIDECerenovus, Inc.QJP2025-09-26