DYB — Introducer, Catheter Class II
FDA product code DYB covers "Introducer, Catheter", a Class II medical device regulated under 21 CFR 870.1340. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DYB
- Device Class
- Class II
- Regulation Number
- 870.1340
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253526 | Medline Industries | NAMIC Dilator and Sheath | Jul 29, 2026 |
| K261529 | Hartman Medical Group | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Mic | Jul 6, 2026 |
| K261242 | Pendracare | SimplGuide | Jun 25, 2026 |
| K261950 | Health Line International Corporation | Health Line Tearaway Introducer | Jun 22, 2026 |
| K261492 | Centerpoint Systems | FieldFlex Steerable Sheath | Jun 5, 2026 |
| K260606 | Echo Medical | Echo Large Bore Introducer Sheath | Apr 29, 2026 |
| K254248 | Cardiocycle Medical(Suzhou) Co | Introducer Sheath Set | Apr 23, 2026 |
| K254279 | Edwards Lifesciences | Edwards eSheath+ introducer set | Apr 17, 2026 |
| K260091 | Inquis Medical | Aventus Introducer Sheath | Apr 13, 2026 |
| K260839 | Protaryx Medical | Protaryx Transseptal Puncture Device (PTX2-001) | Apr 10, 2026 |
| K260942 | Centerpoint Systems | AuST Steerable Sheath | Apr 7, 2026 |
| K260459 | Zoll Respicardia | VANES Delivery System (VDS) | Apr 6, 2026 |
| K260626 | Vizaramed | Multiflex Steerable Sheath 17.5F | Mar 26, 2026 |
| K260163 | Centerpoint Systems | AuST CSP Introducer | Feb 19, 2026 |
| K254236 | Vascutech Medical | Peel-Away Introducer Sheath | Feb 9, 2026 |
| K253652 | Cultiv8 1 | Genie MAX Large Bore Introducer Sheath | Jan 22, 2026 |
| K252508 | Inari Medical | Intri26 Introducer Sheath | Dec 17, 2025 |
| K253741 | Argon Medical Devices | VStick Vascular Access Set | Dec 15, 2025 |
| K252309 | Vivasure Medical Limited | PerQseal Introducers | Oct 23, 2025 |
| K251838 | Cardiocycle Medical(Suzhou) Co | Introducer Sheath Set | Oct 21, 2025 |