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 |
|---|---|---|---|
| K261529 | hartman medical group | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Mic | July 6, 2026 |
| K261242 | pendracare | SimplGuide | June 25, 2026 |
| K261950 | health line international corporation | Health Line Tearaway Introducer | June 22, 2026 |
| K261492 | centerpoint systems | FieldFlex Steerable Sheath | June 5, 2026 |
| K260606 | echo medical | Echo Large Bore Introducer Sheath | April 29, 2026 |
| K254248 | cardiocycle medical(suzhou) co | Introducer Sheath Set | April 23, 2026 |
| K254279 | edwards lifesciences | Edwards eSheath+ introducer set | April 17, 2026 |
| K260091 | inquis medical | Aventus Introducer Sheath | April 13, 2026 |
| K260839 | protaryx medical | Protaryx Transseptal Puncture Device (PTX2-001) | April 10, 2026 |
| K260942 | centerpoint systems | AuST Steerable Sheath | April 7, 2026 |
| K260459 | zoll respicardia | VANES Delivery System (VDS) | April 6, 2026 |
| K260626 | vizaramed | Multiflex Steerable Sheath 17.5F | March 26, 2026 |
| K260163 | centerpoint systems | AuST CSP Introducer | February 19, 2026 |
| K254236 | vascutech medical | Peel-Away Introducer Sheath | February 9, 2026 |
| K253652 | cultiv8 1 | Genie MAX Large Bore Introducer Sheath | January 22, 2026 |
| K252508 | inari medical | Intri26 Introducer Sheath | December 17, 2025 |
| K253741 | argon medical devices | VStick Vascular Access Set | December 15, 2025 |
| K252309 | vivasure medical limited | PerQseal Introducers | October 23, 2025 |
| K251838 | cardiocycle medical(suzhou) co | Introducer Sheath Set | October 21, 2025 |
| K252766 | abiomed | 14Fr Low Profile Introducer Kit | October 8, 2025 |