Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter
FDA 510(k) K181042 · Boston Scientific Corporation
510(k) numberK181042
Submission
- Device name
- Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- April 19, 2018
- Decision date
- May 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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|---|---|---|---|
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| K911384 | Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600DXK · Traditional | Endosonics Corp. | 06/25/1991SE |
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| K904978 | Software Program Used W/Prism ProductsDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904977 | Cine/View Plus - Cardiology WorkstationDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904976 | Cine'View - Stress Echo & Image ReviewDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904975 | Vista Viewing StationDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
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Questions and answers
When was Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter cleared by the FDA?
Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter (K181042) received a 510(k) decision of Substantially Equivalent on May 17, 2018, 28 days after the submission was received.
What is the product code of K181042?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.