Epicardial Access System
FDA 510(k) K213582 · Baylis Medical Company, Inc.
510(k) numberK213582
Submission
- Device name
- Epicardial Access System
- Applicant
- Baylis Medical Company, Inc.
Mississauga, CA - Received
- November 12, 2021
- Decision date
- June 30, 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
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| 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 |
| 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 Epicardial Access System cleared by the FDA?
Epicardial Access System (K213582) received a 510(k) decision of Substantially Equivalent on June 30, 2022, 230 days after the submission was received.
What is the product code of K213582?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.