C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)— 510(k) K240457
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K240457 for C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System), Substantially Equivalent on 2024-07-24. Applicant: Pentax of America, Inc..
Clearance details
- Applicant
- Pentax of America, Inc.
- Product code
- Code GEH
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
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.