IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK— 510(k) K954622
Substantially EquivalentBoston Scientific /International Technologies
FDA 510(k) clearance K954622 for IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK, Substantially Equivalent on 1996-04-29. Applicant: Boston Scientific /International Technologies.
Clearance details
- Applicant
- Boston Scientific /International Technologies
- Product code
- Code DQX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.