ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER— 510(k) K993648
Substantially EquivalentBoston Scientific Corporation Northwest Technology
FDA 510(k) clearance K993648 for ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER, Substantially Equivalent on 1999-11-24. Applicant: Boston Scientific Corporation Northwest Technology.
Clearance details
- Applicant
- Boston Scientific Corporation Northwest Technology
- Product code
- Code MCW
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redmond, WA, US
Adverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
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.