Paragon 8F Balloon Guide Catheter— 510(k) K232437
Substantially EquivalentWallaby Medical
FDA 510(k) clearance K232437 for Paragon 8F Balloon Guide Catheter, Substantially Equivalent on 2023-10-13. Applicant: Wallaby Medical.
Clearance details
- Applicant
- Wallaby Medical
- Product code
- Code DQY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laguna Hills, CA, US
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.