VersaCross Connect Transseptal Dilator
FDA 510(k) K220414 · Baylis Medical Company, Inc.
510(k) numberK220414
Submission
- Device name
- VersaCross Connect Transseptal Dilator
- Applicant
- Baylis Medical Company, Inc.
Mississauga, CA - Received
- February 14, 2022
- Decision date
- May 9, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code DYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…DYB · Traditional | Hartman Medical Group, LLC | 07/06/2026SE |
| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| 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 |
| K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathDYB · Traditional | 12/20/2023SE |
| 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 |
| K201288 | ExpanSure Large Access Transseptal DilatorDRE · Special | 06/12/2020SE |
| K191546 | Epicardial Access SystemDYB · Traditional | 08/02/2019SE |
Questions and answers
When was VersaCross Connect Transseptal Dilator cleared by the FDA?
VersaCross Connect Transseptal Dilator (K220414) received a 510(k) decision of Substantially Equivalent on May 9, 2022, 84 days after the submission was received.
What is the product code of K220414?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.