SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS— 510(k) K961999
Substantially EquivalentBoston Scientific Scimed, Inc.
FDA 510(k) clearance K961999 for SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS, Substantially Equivalent on 1996-11-19. Applicant: Boston Scientific Scimed, Inc..
Clearance details
- Applicant
- Boston Scientific Scimed, Inc.
- Product code
- Code DYG
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Adverse events under product code DYG
product code DYG- Death
- 18
- Malfunction
- 1,051
- Other
- 1
- Total
- 1,070
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.