HI-TORQUE BALANCE MIDDLEWEIGHT ELITE— 510(k) K103101
Substantially EquivalentAbbott Vascular-Cardiac Therapies
FDA 510(k) clearance K103101 for HI-TORQUE BALANCE MIDDLEWEIGHT ELITE, Substantially Equivalent on 2011-02-10. Applicant: Abbott Vascular-Cardiac Therapies. Device class: 2.
Clearance details
- Applicant
- Abbott Vascular-Cardiac Therapies
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Temecula, CA, US
Recent devices under product code DQX
view allMore clearances from Abbott Vascular-Cardiac Therapies
view all- K112957 — HI-TORQUE POWERTURN
- K110134 — NC TREK RX CORONARY DILATATION CATHETER
- K103110 — MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
- K103153 — VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
- K101116 — HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
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.