SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C— 510(k) K011988
Substantially EquivalentCardiofocus, Inc.
FDA 510(k) clearance K011988 for SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C, Substantially Equivalent on 2001-09-20. Applicant: Cardiofocus, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiofocus, Inc.
- Product code
- Code OCL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norton, MA, US
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More clearances from Cardiofocus, Inc.
view allAdverse events under product code OCL
product code OCL- Death
- 34
- Injury
- 256
- Total
- 290
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.