ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER— 510(k) K844972
Substantially EquivalentAdvanced Cardiovascular Systems, Inc.
FDA 510(k) clearance K844972 for ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER, Substantially Equivalent on 1985-05-16. 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
- Mountain View, CA, US
Recent devices under product code LIT
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- 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.