S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0— 510(k) K002116
Substantially EquivalentMedical Device Consultants, Inc.
FDA 510(k) clearance K002116 for S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0, Substantially Equivalent on 2000-08-09. Applicant: Medical Device Consultants, Inc..
Clearance details
- Applicant
- Medical Device Consultants, Inc.
- Product code
- Code DTQ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- North Attleboro, MA, US
Adverse events under product code DTQ
product code DTQ- Death
- 123
- Malfunction
- 4,822
- Other
- 1
- Total
- 4,946
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.