ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS— 510(k) K950752
Substantially EquivalentAdvanced Cardiovascular Systems, Inc.
FDA 510(k) clearance K950752 for ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS, Substantially Equivalent on 1995-05-15. Applicant: Advanced Cardiovascular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Cardiovascular Systems, Inc.
- 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 Advanced Cardiovascular Systems, Inc.
view all- K012534 — HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
- K000550 — OTW MEGALINK SDS BILIARY STENT SYSTEM
- K994229 — VERIPATH PERIPHERAL GUIDING CATHETER
- K992169 — ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
- K990867 — RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
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.