SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE— 510(k) K955869
Substantially EquivalentScimed Life Systems, Inc.
FDA 510(k) clearance K955869 for SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE, Substantially Equivalent on 1996-03-22. Applicant: Scimed Life Systems, Inc..
Clearance details
- Applicant
- Scimed Life Systems, Inc.
- Product code
- Code MAV
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Adverse events under product code MAV
product code MAV- Malfunction
- 1,433
- Total
- 1,433
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.