IVAS 2-10MM (10 GUAGE) BALLON CATHETER— 510(k) K103807
Substantially EquivalentStryker Corporation
FDA 510(k) clearance K103807 for IVAS 2-10MM (10 GUAGE) BALLON CATHETER, Substantially Equivalent on 2011-06-28. Applicant: Stryker Corporation. Device class: 2.
Clearance details
- Applicant
- Stryker Corporation
- Product code
- Code NDN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
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Adverse events under product code NDN
product code NDN- Death
- 24
- Injury
- 407
- Malfunction
- 1,975
- Total
- 2,406
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.