AcQRef Introducer Sheath
FDA 510(k) K171557 · Acutus Medical, Inc.
510(k) numberK171557
Submission
- Device name
- AcQRef Introducer Sheath
- Applicant
- Acutus Medical, Inc.
Carlsbad, CA, US - Received
- May 30, 2017
- Decision date
- February 6, 2018
- 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
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 |
|---|---|---|
| K233691 | FlexCath Cross Transseptal SolutionDYB · Traditional | 12/17/2023SE |
| K231091 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 07/10/2023SE |
| K230606 | AcQMap® High Resolution Imaging and Mapping SystemDQK · Traditional | 05/02/2023SE |
| K222209 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 10/17/2022SE |
| K220784 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 07/01/2022SE |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009MTD · Traditional | 06/21/2022SE |
| K221044 | AcQGuide® VUE Steerable SheathDRA · Traditional | 05/05/2022SE |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/NeedleDYB · Traditional | 02/08/2022SE |
| K212345 | AcQMap High Resolution Imaging and Mapping SystemDQK · Special | 08/27/2021SE |
| K210680 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 08/05/2021SE |
Questions and answers
When was AcQRef Introducer Sheath cleared by the FDA?
AcQRef Introducer Sheath (K171557) received a 510(k) decision of Substantially Equivalent on February 6, 2018, 252 days after the submission was received.
What is the product code of K171557?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.