ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
FDA 510(k) clearance K950752 · decided 1995-05-15
Clearance details
- K-number
- K950752
- Device name
- ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-17
- Decision date
- 1995-05-15
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnosti recall (Z-2791-2011) | Abbott Vascular | 2011-07-12 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CORONARY DILATATION CATHETERS (P810046/S240) | Advanced Cardiovascular Systems, Inc. | 2010-10-15 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S237) | Advanced Cardiovascular Systems, Inc. | 2010-06-01 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S238) | Advanced Cardiovascular Systems, Inc. | 2010-05-13 |
| SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC (P810046/S236) | Advanced Cardiovascular Systems, Inc. | 2010-04-23 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S234) | Advanced Cardiovascular Systems, Inc. | 2010-03-26 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S232) | Advanced Cardiovascular Systems, Inc. | 2010-02-04 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S230) | Advanced Cardiovascular Systems, Inc. | 2009-07-15 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S231) | Advanced Cardiovascular Systems, Inc. | 2009-05-26 |