SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
FDA 510(k) K231227 · Baylis Medical Company, Inc.
510(k) numberK231227
Submission
- Device name
- SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
- Applicant
- Baylis Medical Company, Inc.
Mississauga, CA - Received
- April 28, 2023
- Decision date
- December 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | 05/29/2025SE |
| K242076 | VersaCross RF WireDXF · Special | 11/01/2024SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | 12/14/2023SE |
| K213898 | ProTrack Pigtail WireDQX · Traditional | 03/01/2023SE |
| K221351 | Mechanical GuidewireDQX · Traditional | 12/19/2022SE |
| K213582 | Epicardial Access SystemDYB · Special | 06/30/2022SE |
| K220414 | VersaCross Connect Transseptal DilatorDYB · Special | 05/09/2022SE |
| K201288 | ExpanSure Large Access Transseptal DilatorDRE · Special | 06/12/2020SE |
| K191546 | Epicardial Access SystemDYB · Traditional | 08/02/2019SE |
Questions and answers
When was SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath cleared by the FDA?
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath (K231227) received a 510(k) decision of Substantially Equivalent on December 20, 2023, 236 days after the submission was received.
What is the product code of K231227?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.