ROTABLATOR ROTATIONAL ANGIOPLASTY— 510(k) K953997
Substantially EquivalentHeart Technology Mfg., Inc.
FDA 510(k) clearance K953997 for ROTABLATOR ROTATIONAL ANGIOPLASTY, Substantially Equivalent on 1995-12-22. Applicant: Heart Technology Mfg., Inc..
Clearance details
- Applicant
- Heart Technology Mfg., Inc.
- Product code
- Code MCW
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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.