SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05— 510(k) K070242
Substantially EquivalentBiosense Webster, Inc.
FDA 510(k) clearance K070242 for SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05, Substantially Equivalent on 2007-05-15. Applicant: Biosense Webster, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosense Webster, Inc.
- Product code
- Code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Diamond Bar, CA, US
Recent devices under product code OBJ
view allMore clearances from Biosense Webster, Inc.
view allAdverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.