PORTACLAMP FLEX— 510(k) K070380
Substantially EquivalentCardio Life Research, S.A.
FDA 510(k) clearance K070380 for PORTACLAMP FLEX, Substantially Equivalent on 2007-06-08. Applicant: Cardio Life Research, S.A.. Device class: 2.
Clearance details
- Applicant
- Cardio Life Research, S.A.
- Product code
- Code DXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Claremont, NH, US
Recent devices under product code DXC
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More clearances from Cardio Life Research, S.A.
view allAdverse events under product code DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
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.