ULTRAFLEX— 510(k) K963241
Substantially Equivalent - Subject to Tracking Reg.Boston Scientific Corp
FDA 510(k) clearance K963241 for ULTRAFLEX, Substantially Equivalent - Subject to Tracking Reg. on 1996-11-14. Applicant: Boston Scientific Corp.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code JCT
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Natick,, MA, US
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.