FDA.reportPublic FDA data

Cardiac transseptal access set

Definition
A 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.
GUDID devices
1,166
Last updated
2026-08-12 10:10:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10851498007463CrossWise RF Transseptal SystemCIRCA Scientific, Inc.CW-1010C2026-07-31
10851498007470CrossWise RF Transseptal SystemCIRCA Scientific, Inc.CW-1013A2026-07-31
00864795000108Dexterity Steerable IntroducerPRIMO MEDICAL GROUP9 Fr x 75 cm2023-12-08
00864795000139Dexterity Steerable IntroducerPRIMO MEDICAL GROUP14 Fr x 80 cm2023-12-08
00884450169070HeartSpan®Merit Medical008844501690702018-06-11
00884450169117HeartSpan®Merit Medical008844501691172018-06-11
00884450169131HeartSpan®Merit Medical008844501691312018-06-11
00884450169148HeartSpan®Merit Medical008844501691482017-02-08
00884450169155HeartSpan®Merit Medical008844501691552017-02-21
00884450169162HeartSpan®Merit Medical008844501691622018-06-11
00884450169179HeartSpan®Merit Medical008844501691792017-02-22
00884450169186HeartSpan®Merit Medical008844501691862018-06-11
00884450169193HeartSpan®Merit Medical008844501691932018-06-11
00884450169209HeartSpan®Merit Medical008844501692092018-06-11
00884450466605TSX™Merit Medical Systems, Inc.008844504666052021-05-28
00884450466612TSX™Merit Medical Systems, Inc.008844504666122021-05-28
00884450466629TSX™Merit Medical Systems, Inc.008844504666292021-05-28
00884450466636TSX™Merit Medical Systems, Inc.008844504666362021-05-28
00884450466650TSX™Merit Medical Systems, Inc.008844504666502021-05-28
00884450466667TSX™Merit Medical Systems, Inc.008844504666672021-05-28
00884450466674TSX™Merit Medical Systems, Inc.008844504666742021-05-28
00884450466681TSX™Merit Medical Systems, Inc.008844504666812021-05-28
00884450466704TSX™Merit Medical Systems, Inc.008844504667042021-05-28
00884450484517HeartSpan®Merit Medical008844504845172020-07-29
00884450484524HeartSpan®Merit Medical008844504845242020-08-11
00884450489727HeartSpan®Merit Medical Systems, Inc.008844504897272020-08-10
00850057445275HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020022025-10-01
00850057445282HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020032025-10-01
00850057445299HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020042025-10-01
00850057445305HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020052025-10-01
00850057445312HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020062025-10-01
00850057445329HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020072025-10-01
00850057445336HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020082025-10-01
00850057445343HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020092025-10-01
00850057445350HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020102025-10-01
00850057445367HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020112025-10-01
00850057445374HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020122025-10-01
00850057445381HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020132025-10-01
00850057445398HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020142025-10-01
00850057445404HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020152025-10-02
00850057445411HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020162025-10-02
00850057445428HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020172025-10-02
00850057445435HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020182025-10-02
00850057445442HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020192025-10-02
00850057445459HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020202025-10-02
00850057445466HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020212025-10-02
00850057445473HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020222025-10-02
00850057445480HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020232025-10-02
00850057445497HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020242025-10-02
00850057445503HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020252025-10-02
00850057445510HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020262025-10-02
00850057445527HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020272025-10-02
00850057445534HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020282025-10-02
00850057445541HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020292025-10-02
00850057445558HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020302025-10-02
00850057445565HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020312025-10-02
00850057445572HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020322025-10-02
00850057445589HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020332025-10-02
00850057445596HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020342025-10-02
00850057445602HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020352025-10-02
00850057445619HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020362025-10-02
00850057445268HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9020012025-09-26
00850057445008HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010002025-06-12
00850057445015HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010052025-06-12
00850057445022HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010012025-06-12
00850057445039HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010022025-06-12
00850057445046HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010032025-06-12
00850057445053HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010042025-06-12
00850057445060HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010062025-06-12
00850057445077HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010072025-06-12
00850057445084HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010082025-06-12
00850057445091HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010092025-06-12
00850057445107HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010102025-06-12
00850057445114HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010112025-06-12
00850057445121HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010122025-06-12
00850057445138HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010132025-06-12
00850057445145HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010152025-06-12
00850057445152HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010142025-06-12
00850057445169HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010162025-06-12
00850057445176HOTWIRE™ RF GUIDEWIREAtraverse Medical, Inc9010172025-06-12