ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM— 510(k) K141584
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K141584 for ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM, Substantially Equivalent on 2014-10-16. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- 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
Recent devices under product code JCT
view allMore clearances from Boston Scientific Corporation
view allAdverse 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 →
Recalls naming K141584
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141584.
Data sourced from openFDA. This site is unofficial and independent of the FDA.