SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER— 510(k) K943622
Substantially EquivalentBoston Scientific Scimed, Inc.
FDA 510(k) clearance K943622 for SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER, Substantially Equivalent on 1994-11-30. Applicant: Boston Scientific Scimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Scimed, Inc.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.