510(k) K160173
- Device
- Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K160173
- Product code
- DXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-02-26
- Date received
- 2016-01-27
- Regulation
- 870.2330
- Classification name
- Echocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Eric Elliott
- Address
- 47215 Lakeview Blvd. Fremont CA US 94538 94538
FDA Registration Numbers#
- 3007738736
- 3019130
- 2134265
- 2124215
- 3007695959
- 3006382185
Source Documents#
Other 510(k) Records For Product Code DXK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181042 | Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2018-05-17 |
| K031148 | IN-VISION IMAGING SYSTEM | Jomed, Inc. | 2003-05-28 |
| K934887 | 9750 ATHENA ETHERNET OPTION | S & W Medico Teknik A/S | 1994-01-14 |
| K913209 | ACCESSORY TO GENESIS III (GCFM) | Biosound, Inc. | 1992-05-15 |
| K911384 | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 | Endosonics Corp. | 1991-06-25 |
| K904832 | MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST | Hewlett-Packard Co. | 1991-04-22 |
| K904978 | SOFTWARE PROGRAM USED W/PRISM PRODUCTS | Prism Imaging, Inc. | 1991-02-25 |
| K904977 | CINE/VIEW PLUS - CARDIOLOGY WORKSTATION | Prism Imaging, Inc. | 1991-02-25 |
| K904976 | CINE'VIEW - STRESS ECHO & IMAGE REVIEW | Prism Imaging, Inc. | 1991-02-25 |
| K904975 | VISTA VIEWING STATION | Prism Imaging, Inc. | 1991-02-25 |
| K910029 | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION | Spacelabs, Inc. | 1991-01-31 |
| K903839 | INTERSPEC APOGEE | Interspec, Inc. | 1990-11-16 |
| K903710 | WASHINGTON CARDIAC MONITOR | Washington Biolab, Inc. | 1990-11-09 |
| K901592 | MODEL MD-5 DOPPLER | D. E. Hokanson, Inc. | 1990-10-22 |
| K903414 | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN | Echo Ultrasound | 1990-09-19 |
Legacy Summary#
summary
FDA Review#
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