MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE— 510(k) K021010
Substantially EquivalentEndocare, Inc.
FDA 510(k) clearance K021010 for MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE, Substantially Equivalent on 2002-06-06. Applicant: Endocare, Inc.. Device class: 2.
Clearance details
- Applicant
- Endocare, 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
- Special
- Location
- Irvine, CA, US
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More clearances from Endocare, 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.