FDA.reportPublic FDA data

Abiomed 14Fr Low Profile Introducer

Primary DI
00813502013269
Brand
Abiomed 14Fr Low Profile Introducer
Company
Abiomed, Inc.
Model
1000458
Catalog number
1000458
Device description
Kit, Low Profile, 14Fr, 25cm,Sheath Lock
Published
2024-05-13
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222113000Abiomed 14Fr Low Profile Introducer SetAbiomed, Inc.2022-10-13DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813502013269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813502013269008135020132698135020132690813502013269

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
050636737
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813502013009Abiomed Low Profile Introducer Kit10004352026-01-12
00813502010411Impella RP Flex Introducer Kit20003422026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer Kit0052-3052 2026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit 0052-3053 2026-03-11
00813502011678Abiomed Impella14Fr Introducer Kit, 13cm & 25cm0052-30462026-02-25
00813502013566Impella CP with SmartAssist100041310004132025-11-14
00813502010220Impella 14Fr Introducer Kit, long0052-00172025-10-16
00813502010015Impella0052-00110052-00112016-10-21
00813502011173Impella0046830046832014-09-03
00813502012729Impella10005340052-00382023-10-27
00813502012736Impella10005350052-00392023-10-27
00813502011388Impella0048-00320048-00032023-07-31
00813502011371Impella0048-00240048-00032019-04-18
00813502011876Impella0048-00450048-00032023-07-31
00813502012279Impella10000800048-00032023-07-31
00813502013474Impella100055010005502023-10-27
00813502012910Impella100044110004412023-06-30
00813502012996Impella100043410004342023-05-31
00813502013252Impella100045710004572023-05-31
00813502011791Impella0052-30690052-30692020-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244501990Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502003Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502010Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502027Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502034Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502041Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502058Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502065Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502072Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502089Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502096Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502102Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502119Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502126Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502133Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502140Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502157Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502164Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502171Catapult Guide SheathContract Medical International GmbHDYB2023-09-01