HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH— 510(k) K101116
Substantially EquivalentAbbott Vascular-Cardiac Therapies
FDA 510(k) clearance K101116 for HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH, Substantially Equivalent on 2010-06-23. Applicant: Abbott Vascular-Cardiac Therapies.
Clearance details
- Applicant
- Abbott Vascular-Cardiac Therapies
- Product code
- Code DQX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Temecula, CA, 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.