GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I— 510(k) K093729
Substantially EquivalentHemcon Medical Technologies Europe, Ltd.
FDA 510(k) clearance K093729 for GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I, Substantially Equivalent on 2010-06-08. Applicant: Hemcon Medical Technologies Europe, Ltd..
Clearance details
- Applicant
- Hemcon Medical Technologies Europe, Ltd.
- Product code
- Code QSY
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
Adverse events under product code QSY
product code QSY- Death
- 5
- Other
- 1
- Total
- 6
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.