FDA.reportPublic FDA data

ACCESS25 Delivery Microcatheter

Primary DI
00815948029743
Brand
ACCESS25 Delivery Microcatheter
Company
PENUMBRA, INC.
Model
PXACSTR-A
Device description
ACCESS25 150Micro, Straight
Published
2024-12-16
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
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242033000Access25™ Delivery MicrocatheterPenumbra, Inc.2024-12-11QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815948029743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948029743008159480297438159480297430815948029743

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.

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
00815948025134BenchmarkBMK6F95M-A2023-01-05
00815948025141BenchmarkBMK6F105-A2023-01-05
00815948025158BenchmarkBMK6F105M-A2023-01-05
00815948025165BenchmarkBMK6F115-A2023-01-05
00815948025172BenchmarkBMK6F115M-A2023-01-05
00815948025189BenchmarkBMK6F95BER120-A2023-01-05
00815948025196BenchmarkBMK6F95SIM120-A2023-01-05
00815948025202BenchmarkBMK6F95MBER120-A2023-01-05
00815948025219BenchmarkBMK6F95MSIM120-A2023-01-05
00815948025226BenchmarkBMK6F105BER130-A2023-01-05
00815948025233BenchmarkBMK6F105SIM130-A2023-01-05
00815948025240BenchmarkBMK6F105MBER130-A2023-01-05
00815948025257BenchmarkBMK6F105MSIM130-A2023-01-05
00815948022553Indigo SystemLITNG12HTORQ100-A2020-07-15
00815948022560Indigo SystemLITNG12XTORQ100-A2020-07-15
00815948022577Indigo SystemLITNG12HTORQ115-A2020-07-15
00815948022591Indigo SystemLITNG12XTORQ115-A2020-07-15
00815948022904Indigo SystemLITNG12HTORQ1002020-07-15
00815948022911Indigo SystemLITNG12XTORQ1002020-07-15
00815948022928Indigo SystemLITNG12HTORQ1152020-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
00763000539351RebarMicro Therapeutics, Inc.QJP2022-02-27
07613327519372AXS VECTA 46Stryker CorporationQJP2021-12-17
07613327313956Trevo Trak 21Stryker CorporationQJP2020-04-17
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270353Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270360Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270377Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270384Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270520Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270537Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270551Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270766Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270773Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270216Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270223Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270230Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270247Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270254Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270292Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270308Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07