FDA.reportPublic FDA data

PathBuilder Transseptal Guiding Introducer

Primary DI
06952450956991
Brand
PathBuilder Transseptal Guiding Introducer
Company
Shanghai Microport Ep Medtech Co., Ltd.
Model
TSL2638
Published
2024-02-26
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212626000PathBuilder Transseptal Guiding IntroducerShanghai Microport EP Medtech Co., Ltd.2022-03-23DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06952450956991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06952450956991069524509569916952450956991

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal access setA collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542965535
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06952450910016 PathBuilder Transseptal NeedleTNS56192024-02-22
06952450910023 PathBuilder Transseptal NeedleTNM56192024-02-22
06952450910030 PathBuilder Transseptal NeedleTNM71182024-02-22
06952450910047 PathBuilder Transseptal NeedleTNM89182024-02-22
06952450910054 PathBuilder Transseptal NeedleTNM98182024-02-22
06952450910061PathBuilder Transseptal NeedleTNL71182024-02-22
06952450910078PathBuilder Transseptal NeedleTNL98182024-02-22
06952450910085 PathBuilder Transseptal NeedleTNL89182024-02-22
06952450948101PathBuilder Transseptal Guiding IntroducerTSL163 8 2024-02-26
06952450948118PathBuilder Transseptal Guiding IntroducerTSL481852024-02-26
06952450948125PathBuilder Transseptal Guiding IntroducerTSL481852024-02-26
06952450948132PathBuilder Transseptal Guiding IntroducerTSL481852024-02-26
06952450948149PathBuilder Transseptal Guiding IntroducerTSL16385 2024-02-26
06952450956878PathBuilder Transseptal Guiding IntroducerTSL0818 2024-02-26
06952450956885PathBuilder Transseptal Guiding IntroducerTSL1818 2024-02-26
06952450956892PathBuilder Transseptal Guiding IntroducerTSL08185 2024-02-26
06952450956908PathBuilder Transseptal Guiding IntroducerTSL18185 2024-02-26
06952450956915PathBuilder Transseptal Guiding IntroducerTSR0638 2024-02-26
06952450956922PathBuilder Transseptal Guiding IntroducerTSR1638 2024-02-26
06952450956939PathBuilder Transseptal Guiding IntroducerTSR06385 2024-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08498840011300VYGONVygon CorporationDYB2019-04-08
08498840011317VYGONVygon CorporationDYB2019-04-08
08498840011751VYGONVygon CorporationDYB2019-04-08
08498840011768VYGONVygon CorporationDYB2019-04-08
08498840011775VYGONVygon CorporationDYB2019-04-08
08498840011782VYGONVygon CorporationDYB2019-04-08
08498840011799VYGONVygon CorporationDYB2019-04-08
08498840011805VYGONVygon CorporationDYB2019-04-08
08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
00813502010664Introducer Kit for Impella®Oscor Inc.DYB2017-11-30
00813502010237Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010244Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010558Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
H965355010ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355030ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355060ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355080ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355090ENVINAVILYST MEDICAL, INC.DYB2017-08-07