VASCUTRAK II PTA DILATATION CATHETER— 510(k) K073025
Substantially EquivalentThermopeutix, Inc. Dba Ymed, Inc.
FDA 510(k) clearance K073025 for VASCUTRAK II PTA DILATATION CATHETER, Substantially Equivalent on 2007-11-09. Applicant: Thermopeutix, Inc. Dba Ymed, Inc..
Clearance details
- Applicant
- Thermopeutix, Inc. Dba Ymed, Inc.
- Product code
- Code PNO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Adverse events under product code PNO
product code PNO- Malfunction
- 1,646
- Total
- 1,646
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.