Impella CP Introducer
FDA 510(k) K192769 · Abiomed, Inc.
510(k) numberK192769
Submission
- Device name
- Impella CP Introducer
- Applicant
- Abiomed, Inc.
Danvers, MA, US - Received
- September 30, 2019
- Decision date
- November 18, 2019
- 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
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| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
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| 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 |
| K241708 | Abiomed 14Fr Low Profile Introducer KitDYB · Traditional | 08/06/2024SE |
| 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 |
| 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 Impella CP Introducer cleared by the FDA?
Impella CP Introducer (K192769) received a 510(k) decision of Substantially Equivalent on November 18, 2019, 49 days after the submission was received.
What is the product code of K192769?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.