SurfRider 13 Microcatheter

Primary DI
00810201980007
Brand
SurfRider 13 Microcatheter
Company
KANEKA AMERICAS HOLDING INC
Model
N01-13165-ST
Device description
SurfRider 13 Microcatheters are single lumen devices designed to aid the physician in accessing distal neuro vasculature when used with a guide catheter and steerable guidewire. There are two models of the SurfRider 13 Microcatheter, steam shapeable straight tip and a pre-shaped J tip. Both have an effective length of 165cm. The microcatheter is packaged and sterilized with the shaping mandrel and an intruder sheath. This model is the straight tip.
Published
2026-02-17
Public version status
New
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
KRACatheter, Continuous Flush
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251668000SurfRider 13 MicrocatheterKaneka Americas Holding, Inc.2026-01-05QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810201980007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810201980007008102019800078102019800070810201980007

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length165Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7079532615darci@tplconsulting.net

Regulatory Flags#

DUNS number
026390974
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810201980014SurfRider 13 MicrocatheterN01-13165-PS2026-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023825Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023832Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023849Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023856Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023863Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023870Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023894Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023900Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023924Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023931Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023948Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
07613327519372AXS VECTA 46Stryker CorporationQJP2021-12-17
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07613327313956Trevo Trak 21Stryker CorporationQJP2020-04-17
07613327459241AXS VECTA 74Stryker CorporationQJP2019-02-19
07613327459258AXS VECTA 74Stryker CorporationQJP2019-02-19
07613327459265AXS VECTA 74Stryker CorporationQJP2019-02-19
07613327459210AXS VECTA 71Stryker CorporationQJP2018-10-26
07613327459227AXS VECTA 71Stryker CorporationQJP2018-10-26
07613327459234AXS VECTA 71Stryker CorporationQJP2018-10-26
07640132622157M-CATH MicrocatheterAcrostak (Schweiz) AGKRA2018-05-15
08714729235118Renegadeā„¢BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24