FDA.reportPublic FDA data

8F Base Camp system 2.0 80cm

Primary DI
00853799007718
Brand
8F Base Camp system 2.0 80cm
Company
ROUTE 92 MEDICAL
Model
Gen 2.0
Catalog number
5001-2-80B
Device description
8F Base Camp system 2.0 80cm: Contains 8F Base Camp system 2.0 80cm (00853799007701)
Published
2024-10-14
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
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2405290008F Modified Sheath SystemRoute 92 Medical, Inc.2024-10-02QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853799007718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853799007718008537990077188537990077180853799007718

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). 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
008537990077258F Base Camp system 2.0 90cmGen 2.05001-2-90B2024-10-14
008537990079308F Base Camp System 2.0 90cmGen 2.05001-2-90B2026-07-08
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
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
Primary DIBrandCompanyProduct codePublished
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10801902220445ARROWTELEFLEX INCORPORATEDDQY2026-08-01
00850074235132Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-07-31
08718122006153Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122006160Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008188Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008195Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122013922Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122014103Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122028902Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
10841156108915TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-30
10801902196719ARROWTELEFLEX INCORPORATEDDQY2026-07-29
10841156108892TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-29
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
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