018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter— 510(k) K242419
Substantially EquivalentCreagh Medical Ltd. Dba Surmodics, Inc.
FDA 510(k) clearance K242419 for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter, Substantially Equivalent on 2024-11-15. Applicant: Creagh Medical Ltd. Dba Surmodics, Inc..
Clearance details
- Applicant
- Creagh Medical Ltd. Dba Surmodics, Inc.
- Product code
- Code LIT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ballinasloe, IE
Adverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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.