CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER— 510(k) K140733
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K140733 for CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER, Substantially Equivalent on 2014-04-28. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code MTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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More clearances from Boston Scientific Corporation
view allAdverse events under product code MTD
product code MTD- Death
- 22
- Injury
- 376
- Malfunction
- 986
- Total
- 1,384
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.