CHOCOLATE PTCA BOLLOON CATHETER— 510(k) K133633
Substantially EquivalentTrireme Medical, Inc.
FDA 510(k) clearance K133633 for CHOCOLATE PTCA BOLLOON CATHETER, Substantially Equivalent on 2014-06-02. Applicant: Trireme Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Trireme Medical, Inc.
- Product code
- Code LOX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code LOX
view allMore clearances from Trireme Medical, Inc.
view all- 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
- K120677 — CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
Adverse events under product code LOX
product code LOX- Death
- 190
- Injury
- 1,498
- Malfunction
- 9,670
- Total
- 11,358
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.