Abbott Vascular-Cardiac Therapies
Temecula, CA, US
Abbott Vascular-Cardiac Therapies appears in FDA device records in Temecula, CA. FDA records list 6 510(k) clearances between and , 15 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 6
- PMA records
- 15
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 6 510(k) clearances for Abbott Vascular-Cardiac Therapies between 2010 and 2011. The busiest year on record is 2011, with 4. The most recent is 2011, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2011 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112957 | HI-TORQUE POWERTURN | DQX | Substantially Equivalent | |
| K110134 | NC TREK RX CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | |
| K103101 | HI-TORQUE BALANCE MIDDLEWEIGHT ELITE | DQX | Substantially Equivalent | |
| K103110 | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER | LOX | Substantially Equivalent | |
| K103153 | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | |
| K101116 | HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH | DQX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain