CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)— 510(k) K120677
Substantially EquivalentTrireme Medical, Inc.
FDA 510(k) clearance K120677 for CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014), Substantially Equivalent on 2012-03-15. Applicant: Trireme Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Trireme Medical, 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
- Special
- Location
- Pleasanton, CA, US
Recent devices under product code LIT
view allMore clearances from Trireme Medical, Inc.
view all- K133633 — CHOCOLATE PTCA BOLLOON CATHETER
- K130414 — CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018
- K122070 — CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
- K121681 — GLIDER PTCA BALLOON CATHETER
- K121402 — CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G
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.