Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
FDA 510(k) clearance K160173 · decided 2016-02-26
Clearance details
- K-number
- K160173
- Device name
- Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-01-27
- Decision date
- 2016-02-26
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DXK
- Device class
- 2
- Regulation number
- 870.2330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boston Scientific Corporation
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (K181042) | Boston Scientific Corporation | 2018-05-17 |
| IN-VISION IMAGING SYSTEM (K031148) | Jomed, Inc. | 2003-05-28 |
| 9750 ATHENA ETHERNET OPTION (K934887) | S & W Medico Teknik A/S | 1994-01-14 |
| ACCESSORY TO GENESIS III (GCFM) (K913209) | Biosound, Inc. | 1992-05-15 |
| CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (K911384) | Endosonics Corp. | 1991-06-25 |
| MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (K904832) | Hewlett-Packard Co. | 1991-04-22 |
| VISTA VIEWING STATION (K904975) | Prism Imaging, Inc. | 1991-02-25 |
| SOFTWARE PROGRAM USED W/PRISM PRODUCTS (K904978) | Prism Imaging, Inc. | 1991-02-25 |
| CINE'VIEW - STRESS ECHO & IMAGE REVIEW (K904976) | Prism Imaging, Inc. | 1991-02-25 |
| CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (K904977) | Prism Imaging, Inc. | 1991-02-25 |
| PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (K910029) | Spacelabs, Inc. | 1991-01-31 |
| INTERSPEC APOGEE (K903839) | Interspec, Inc. | 1990-11-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Axonics Sacral Neuromodulation System (P180046/S113) | Boston Scientific Corporation | 2026-08-07 |
| Axonics Sacral Neuromodulation System (P190006/S113) | Boston Scientific Corporation | 2026-08-07 |
| Innova Self Expanding Stent System (P140028/S087) | Boston Scientific Corporation | 2026-08-06 |
| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S043) | Boston Scientific Corporation | 2026-08-04 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S009) | Boston Scientific Corporation | 2026-07-30 |
| Axonics Sacral Neuromodulation System (P180046/S110) | Boston Scientific Corporation | 2026-07-24 |
| Axonics Sacral Neuromodulation System (P190006/S110) | Boston Scientific Corporation | 2026-07-24 |
| S-ICD EMBLEM GEN 2 (A209); S-ICD EMBLEM MRI (A219) (P110042/S215) | Boston Scientific Corporation | 2026-07-23 |