LOW PROFILE STEERABLE BALLOON DILATA— 510(k) K831403
Substantially EquivalentAdvanced Cardiovascular Systems, Inc.
FDA 510(k) clearance K831403 for LOW PROFILE STEERABLE BALLOON DILATA, Substantially Equivalent on 1983-06-08. Applicant: Advanced Cardiovascular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code LIT
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 LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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.