DYB · Introducer, Catheter
Cardiovascular · 21 CFR 870.1340 · Class 2
Overview
| Product Code | DYB |
|---|---|
| Device Name | Introducer, Catheter |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 705)
Showing 20 most recent of 705 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC | Jul 6, 2026 | SESE |
| K261242 | SimplGuide | Pendracare | Jun 25, 2026 | SESE |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | Jun 22, 2026 | SESE |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | Jun 5, 2026 | SESE |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | Apr 29, 2026 | SESE |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | Apr 23, 2026 | SESE |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | Apr 17, 2026 | SESE |
| K260091 | Aventus Introducer Sheath | Inquis Medical | Apr 13, 2026 | SESE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | Apr 10, 2026 | SESE |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | Apr 7, 2026 | SESE |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | Apr 6, 2026 | SESE |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | Mar 26, 2026 | SESE |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | Feb 19, 2026 | SESE |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | Feb 9, 2026 | SESE |
| K253652 | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | Jan 22, 2026 | SESE |
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | Dec 17, 2025 | SESE |
| K253741 | V•Stick™ Vascular Access Set | Argon Medical Devices, Inc. | Dec 15, 2025 | SESE |
| K252309 | PerQseal Introducers | Vivasure Medical Limited | Oct 23, 2025 | SESE |
| K251838 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | Oct 21, 2025 | SESE |
| K252766 | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | Oct 8, 2025 | SESE |
Top Applicants
- St Jude Medical — 21 clearances
- Cordis Corp. — 19 clearances
- Terumo Medical Corp. — 19 clearances
- Daig Corp. — 18 clearances
- Merit Medical Systems, Inc. — 18 clearances
