MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE— 510(k) K072552
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K072552 for MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE, Substantially Equivalent on 2007-12-14. 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.