CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER— 510(k) K030966
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K030966 for CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER, Substantially Equivalent on 2003-09-23. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code NAJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Glens Falls, NY, US
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Adverse events under product code NAJ
product code NAJ- Death
- 3
- Total
- 3
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.