The CVC WAND Safety Introducer with Valved Peelable Sheath— 510(k) K182243
Substantially EquivalentAccess Scientific, LLC
FDA 510(k) clearance K182243 for The CVC WAND Safety Introducer with Valved Peelable Sheath, Substantially Equivalent on 2018-09-18. Applicant: Access Scientific, LLC.
Clearance details
- Applicant
- Access Scientific, LLC
- Product code
- Code DYB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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.