FDA.reportPublic FDA data

Cardiac transseptal needle, single-use

Definition
A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.
GUDID devices
95
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00858769006104SafeSept Transseptal GuidwirePPMDMSS-1352018-03-02
00858769006111SafeSept Needle Free Transseptal GuidewirePPMDMSSNF2018-03-02
00858769006135Needle Free Transseptal CannulaPPMDMTSC0712018-03-02
00858769006142Needle Free Transseptal CannulaPPMDMTSC0892018-03-02
00858769006159Needle Free Transseptal CannulaPPMDMTSC0982018-03-02
00858769006166Needle Free Transseptal CannulaPPMDMTSC1712018-03-02
00858769006173Needle Free Transseptal CannulaPPMDMTSC1892018-03-02
00858769006180Needle Free Transseptal CannulaPPMDMTSC1982018-03-02
00858769006197Transseptal NeedlePPMDMTSN0712018-11-28
00858769006203Transseptal NeedlePPMDMTSN0892018-11-28
00858769006210Transseptal NeedlePPMDMTSN0982018-11-28
00858769006241Transseptal NeedlePPMDMTSN1892018-11-28
00858769006258Transseptal NeedlePPMDMTSN1982018-11-28
00858769006364SafeSept Blunt NeedlePPMDMSBN0892021-03-15
00858769006371SafeSept Blunt NeedlePPMDMSBN0982021-03-15
00858769006388SafeSept Blunt NeedlePPMDMSBN1712021-03-15
00858769006395SafeSept Blunt NeedlePPMDMSBN1892021-03-15
00858769006401SafeSept Blunt NeedlePPMDMSBN1982021-03-15
00858769006418SafeSept Transseptal GuidewirePPMDMSS-1402022-09-26
00858769006425SafeSharp Transseptal NeedlePPMDMCLICK0712024-07-02
00858769006449SafeSharp Transseptal NeedlePPMDMCLICK0982024-07-02
00858769006456SafeSharp Transseptal NeedlePPMDMCLICK1712024-07-02
00858769006470SafeSharp Transseptal NeedlePPMDMCLICK1982024-07-02
00858769006487SafeSept RF Transseptal GuidewirePPMDMSSRF1322026-03-23
00858769006500SafeSept RF Transseptal GuidewirePPMDMSSRF2322026-03-23
00858769006524SafeSept RF Transseptal GuidewirePPMDMSSRF1352026-03-23
00858769006531SafeSept RF Transseptal GuidewirePPMDMSSRF135R2026-03-23
00858769006548SafeSept RF Transseptal GuidewirePPMDMSSRF2352026-03-23
00858769006555SafeSept RF Transseptal GuidewirePPMDMSSRF235R2026-03-23
00884450021163Merit Medical®Merit Medical Systems, Inc.Initial Release2025-07-01
00884450160923HeartSpan®Merit Medical008844501609232018-06-11
00884450409398Merit Medical®Merit Medical Systems, Inc.008844504093982019-02-08
00884450451656HeartSpan®Merit Medical008844504516562020-08-13
00884450451670HeartSpan®Merit Medical008844504516702020-09-11
00884450451694HeartSpan®Merit Medical008844504516942020-09-08
00884450451700HeartSpan®Merit Medical008844504517002020-09-04
00884450451717TSX™ Transseptal NeedleMerit Medical Systems, Inc.008844504517172020-10-14
00884450489345HeartSpan®Merit Medical Systems, Inc.008844504893452020-11-19
00884450489369HeartSpan®Merit Medical Systems, Inc.008844504893692020-11-19
06952450910016 PathBuilder Transseptal NeedleShanghai Microport Ep Medtech Co., Ltd.TNS56192024-02-22
06952450910023 PathBuilder Transseptal NeedleShanghai Microport Ep Medtech Co., Ltd.TNM56192024-02-22
06952450910030 PathBuilder Transseptal NeedleShanghai Microport Ep Medtech Co., Ltd.TNM71182024-02-22
06952450910047 PathBuilder Transseptal NeedleShanghai Microport Ep Medtech Co., Ltd.TNM89182024-02-22
06952450910054 PathBuilder Transseptal NeedleShanghai Microport Ep Medtech Co., Ltd.TNM98182024-02-22
06952450910061PathBuilder Transseptal NeedleShanghai Microport Ep Medtech Co., Ltd.TNL71182024-02-22
06952450910078PathBuilder Transseptal NeedleShanghai Microport Ep Medtech Co., Ltd.TNL98182024-02-22
06952450910085 PathBuilder Transseptal NeedleShanghai Microport Ep Medtech Co., Ltd.TNL89182024-02-22
00858769006494SafeSept RF Transseptal GuidewirePPMDMSSRF132R2026-03-23
00858769006517SafeSept RF Transseptal GuidewirePPMDMSSRF232R2026-03-23
30858769006488SafeSept RF Transseptal GuidewirePPMDMSSRF1322026-03-23
30858769006501SafeSept RF Transseptal GuidewirePPMDMSSRF2322026-03-23
30858769006525SafeSept RF Transseptal GuidewirePPMDMSSRF1352026-03-23
30858769006532SafeSept RF Transseptal GuidewirePPMDMSSRF135R2026-03-23
30858769006549SafeSept RF Transseptal GuidewirePPMDMSSRF2352026-03-23
30858769006556SafeSept RF Transseptal GuidewirePPMDMSSRF235R2026-03-23
20884450021167Merit Medical®Merit Medical Systems, Inc.Initial Release2025-07-01
00884450630730HeartSpan®Merit Medical Systems, Inc.C2024-09-21
30858769006426SafeSharp Transseptal NeedlePPMDMCLICK0712024-07-02
30858769006440SafeSharp Transseptal NeedlePPMDMCLICK0982024-07-02
30858769006457SafeSharp Transseptal NeedlePPMDMCLICK1712024-07-02
30858769006471SafeSharp Transseptal NeedlePPMDMCLICK1982024-07-02
00884450630723HeartSpan®Merit Medical Systems, Inc.C2024-04-23
00884450630716HeartSpan®Merit Medical Systems, Inc.008844506307162023-10-26
00884450630754HeartSpan®Merit Medical Systems, Inc.008844506307542023-09-30
00884450630747HeartSpan®Merit Medical Systems, Inc.008844506307472023-08-02
30858769006419SafeSept Transseptal GuidewirePPMDMSS-1402022-09-26
00884450489475HeartSpan®Merit Medical Systems, Inc.008844504894752021-10-27
00884450489468HeartSpan®Merit Medical Systems, Inc.008844504894682021-10-12
00884450489444HeartSpan®Merit Medical Systems, Inc.008844504894442021-07-30
00884450489451HeartSpan®Merit Medical Systems, Inc.008844504894512021-07-30
00884450489437HeartSpan®Merit Medical Systems, Inc.008844504894372021-07-29
00858769006357SafeSept Blunt NeedlePPMDMSBN0712021-03-15
30858769006365SafeSept Blunt NeedlePPMDMSBN0892021-03-15
30858769006372SafeSept Blunt NeedlePPMDMSBN0982021-03-15
30858769006389SafeSept Blunt NeedlePPMDMSBN1712021-03-15
30858769006396SafeSept Blunt NeedlePPMDMSBN1892021-03-15
30858769006402SafeSept Blunt NeedlePPMDMSBN1982021-03-15
00884450489406HeartSpan®Merit Medical Systems, Inc.008844504894062021-02-01
00884450489376HeartSpan®Merit Medical Systems, Inc.008844504893762021-01-15
00884450489383HeartSpan®Merit Medical Systems, Inc.008844504893832021-01-15