WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM— 510(k) K000001
Substantially EquivalentBoston Scientific Scimed, Inc.
FDA 510(k) clearance K000001 for WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM, Substantially Equivalent on 2000-06-05. Applicant: Boston Scientific Scimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Scimed, Inc.
- Product code
- Code JCT
- Device class
- Class 2
- Regulation
- 21 CFR 878.3720
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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Adverse events under product code JCT
product code JCT- Death
- 20
- Injury
- 211
- Other
- 1
- Total
- 232
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.