ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED— 510(k) K121048
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K121048 for ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED, Substantially Equivalent on 2012-08-03. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- 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
- Marlboro, MA, 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.