pNOVUS 21 Microcatheter (150cm)

Primary DI
05391530910378
Brand
pNOVUS 21 Microcatheter (150cm)
Company
PHENOX LIMITED
Model
PNOV-21-150
Device description
The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures.
Published
2024-12-02
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

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242420000pNOVUS 21 MicrocatheterPhenox, Ltd.2024-11-12DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530910378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530910378053915309103785391530910378

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 Length150Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985621869
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530910231Esperance pHLO Aspiration SystemPHLO-AC-71-1252026-02-10
05391530910248Esperance pHLO Aspiration SystemPHLO-AC-71-1352026-02-10
05391530910460pRESET® Delta Thrombectomy Device (6mm x 30mm)PRE2-6-302025-03-03
05391530910477pRESET® Delta Thrombectomy Device (4mm x 20mm)PRE2-4-202025-03-03
05391530910484pRESET® Delta Thrombectomy Device (5mm x 40mm)PRE2-5-402025-03-03
05391530910491pRESET® Delta LITE Thrombectomy Device (3mm x 20mm)PRE2-LT-3-202025-03-03
05391530910507pRESET® Delta LITE Thrombectomy Device (4mm x 20mm)PRE2-LT-4-202025-03-03
05391530910392pNOVUS 21 Microcatheter (160cm)PNOV-21-1602024-12-02
05391530910095pRESET® LITE Thrombectomy Device (3mm x 20mm)PRE-LT-3-202023-11-13
05391530910101pRESET® LITE Thrombectomy Device (4mm x 20mm)PRE-LT-4-202023-11-13
05391530910002pRESET® Thrombectomy Device (4mm x 20mm)PRE-4-202023-01-24
05391530910019pRESET® Thrombectomy Device (6mm x 30mm)PRE-6-302023-01-24
05391530910125pRESET® Thrombectomy Device (5mm x 40mm)PRE-5-402023-01-24
05391530910132pNOVUS 21 MicrocatheterPNOV-21-1602023-01-09
05391530910040pORTAL® Steerable Hydrophilic GuidewirePORT-14-200-12020-02-06
05391530910057pORTAL® EXT Extension WirePORT-14-115-1-EX2020-02-06

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