HALO 360 & SIZING BALLOON, MODEL 3441C— 510(k) K093855
Substantially EquivalentBarrx Medical, Incorporated
FDA 510(k) clearance K093855 for HALO 360 & SIZING BALLOON, MODEL 3441C, Substantially Equivalent on 2010-01-15. Applicant: Barrx Medical, Incorporated. Device class: 2.
Clearance details
- Applicant
- Barrx Medical, Incorporated
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Recent devices under product code GEI
view allMore clearances from Barrx Medical, Incorporated
view all- K093008 — HALO ABLATION CATHETER, MODEL 90-9100
- K092487 — HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
- K083737 — HALO ABLATION CATHETER
- K083711 — MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34
- K082202 — HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.