Abiomed 14Fr Low Profile Introducer Kit
FDA 510(k) K241708 · Abiomed, Inc.
510(k) numberK241708
Submission
- Device name
- Abiomed 14Fr Low Profile Introducer Kit
- Applicant
- Abiomed, Inc.
Danvers, MA, US - Received
- June 13, 2024
- Decision date
- August 6, 2024
- 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 |
|---|---|---|
| K252766 | 14Fr Low Profile Introducer KitDYB · Special | 10/08/2025SE |
| K221294 | preCARDIA Occlusion SystemMJN · Traditional | 06/30/2023SESU |
| K223161 | OXY-1 SystemDTZ · Traditional | 02/23/2023SE |
| K222113 | Abiomed 14Fr Low Profile Introducer SetDYB · Traditional | 10/13/2022SE |
| K202330 | Impella XR Sheath SetDYB · Traditional | 12/07/2020SE |
| K200109 | OXY-1 SystemDTZ · Traditional | 10/23/2020SE |
| K201116 | Abiomed 23 Fr SheathDYB · Traditional | 06/15/2020SE |
| K192769 | Impella CP IntroducerDYB · Traditional | 11/18/2019SE |
| K112892 | Impella 2.5 Plus CatheterPBL · Special | 09/06/2012SESU |
| K110845 | Impella Controller with Flow ControlKFM · Special | 04/27/2011SE |
Questions and answers
When was Abiomed 14Fr Low Profile Introducer Kit cleared by the FDA?
Abiomed 14Fr Low Profile Introducer Kit (K241708) received a 510(k) decision of Substantially Equivalent on August 6, 2024, 54 days after the submission was received.
What is the product code of K241708?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.