ASPIRE RX-LP6 ASPIRATION CATHETER— 510(k) K131998
Substantially EquivalentControl Medical Technology, LLC
FDA 510(k) clearance K131998 for ASPIRE RX-LP6 ASPIRATION CATHETER, Substantially Equivalent on 2013-11-26. Applicant: Control Medical Technology, LLC.
Clearance details
- Applicant
- Control Medical Technology, LLC
- Product code
- Code QEZ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Park City, UT, US
Adverse events under product code QEZ
product code QEZ- Death
- 24
- Total
- 24
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.