Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing— 510(k) K151932
Substantially EquivalentStryker Corporation
FDA 510(k) clearance K151932 for Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing, Substantially Equivalent on 2016-03-31. Applicant: Stryker Corporation.
Clearance details
- Applicant
- Stryker Corporation
- Product code
- Code HRX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.