BLUE SUI SLING— 510(k) K121754
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K121754 for BLUE SUI SLING, Substantially Equivalent on 2012-10-10. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code OTN
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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More clearances from Boston Scientific Corp
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- K150303 — XXL Vascular Balloon Dilatation Catheter
Adverse events under product code OTN
product code OTN- Injury
- 6,630
- Total
- 6,630
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.