FDA.reportPublic FDA data

Neuron

Primary DI
00815948027886
Brand
Neuron
Company
PENUMBRA, INC.
Model
PNS5F130SIM-R
Device description
Neur070Select, 130SIM
Published
2023-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083125000NEURON SELECT CATHETER SIZE 070Penumbra, Inc.2008-11-21DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815948027886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948027886008159480278868159480278860815948027886

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

Regulatory Flags#

DUNS number
191077671
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M4244002C03060Penumbra Coil 4004002C03062016-07-30
M4244002C03100Penumbra Coil 4004002C03102016-07-30
M4244002C04080Penumbra Coil 4004002C04082016-07-30
M4244002C04120Penumbra Coil 4004002C04122016-07-30
M4244002C05060Penumbra Coil 4004002C05062016-07-30
M4244002C05100Penumbra Coil 4004002C05102016-07-30
M4244002C06100Penumbra Coil 4004002C06102016-07-30
M4244002C06150Penumbra Coil 4004002C06152016-07-30
M4244002C07100Penumbra Coil 4004002C07102016-07-30
M4244002C07150Penumbra Coil 4004002C07152016-07-30
M4244002C07200Penumbra Coil 4004002C07202016-07-30
M4244002C08150Penumbra Coil 4004002C08152016-07-30
M4244002C08200Penumbra Coil 4004002C08202016-07-30
M4244002C08300Penumbra Coil 4004002C08302016-07-30
M4244002C09150Penumbra Coil 4004002C09152016-07-30
M4244002C09250Penumbra Coil 4004002C09252016-07-30
M4244002C09350Penumbra Coil 4004002C09352016-07-30
M4244002C10200Penumbra Coil 4004002C10202016-07-30
M4244002C10300Penumbra Coil 4004002C10302016-07-30
M4244002C10400Penumbra Coil 4004002C10402016-07-30

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Primary DI, Brand, Company table
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08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270711Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270216Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
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00763000270308Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270315Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270322Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270339Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270391Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07