TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL— 510(k) K973708
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K973708 for TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL, Substantially Equivalent on 1997-12-19. Applicant: Merit Medical Systems, Inc..
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Code DQX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.