FDA.reportPublic FDA data

PathBuilder Transseptal Guiding Introducer

Primary DI
06952450957141
Brand
PathBuilder Transseptal Guiding Introducer
Company
Shanghai Microport Ep Medtech Co., Ltd.
Model
TSR36385
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
06952450957141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06952450957141069524509571416952450957141

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
10801902228700ARROWTELEFLEX INCORPORATEDDYB2026-09-22
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10884450489816Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489823Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489915Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489953Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489960Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27