Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
FDA 510(k) clearance K181042 · decided 2018-05-17
Clearance details
- K-number
- K181042
- Device name
- Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-04-19
- Decision date
- 2018-05-17
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DXK
- Device class
- 2
- Regulation number
- 870.2330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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| 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.
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