FDA.reportPublic FDA data

Tenzing 5 delivery catheter

Primary DI
00853799007619
Brand
Tenzing 5 delivery catheter
Company
ROUTE 92 MEDICAL
Model
Gen 1
Device description
Tenzing 5 delivery catheter
Published
2023-10-16
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
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2
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
00853799007619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853799007619008537990076198537990076190853799007619

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
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

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Primary DI, Brand, Company table
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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
00840303713128Carrier XL Delivery CatheterBALT USA LLCQJP2025-10-24
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