Arrow Stiffening Stylet— 510(k) K220280
Substantially EquivalentArrow International, LLC (A subsidiary of Teleflex, Inc.)
FDA 510(k) clearance K220280 for Arrow Stiffening Stylet, Substantially Equivalent on 2022-08-30. Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.).
Clearance details
- Applicant
- Arrow International, LLC (A subsidiary of Teleflex, Inc.)
- Product code
- Code DRB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Adverse events under product code DRB
product code DRB- Death
- 36
- Injury
- 562
- Total
- 598
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.