ExpanSure Transseptal Dilation System
FDA 510(k) K182064 · Baylis Medical Company, Inc.
510(k) numberK182064
Submission
- Device name
- ExpanSure Transseptal Dilation System
- Applicant
- Baylis Medical Company, Inc.
Mississauga, CA - Received
- August 1, 2018
- Decision date
- March 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
Other 510(k)s with product code DRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
More from Xcardia Innovation , Ltd.
| 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 |
| K220414 | VersaCross Connect Transseptal DilatorDYB · Special | 05/09/2022SE |
| K201288 | ExpanSure Large Access Transseptal DilatorDRE · Special | 06/12/2020SE |
Questions and answers
When was ExpanSure Transseptal Dilation System cleared by the FDA?
ExpanSure Transseptal Dilation System (K182064) received a 510(k) decision of Substantially Equivalent on March 21, 2019, 232 days after the submission was received.
What is the product code of K182064?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.