HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE— 510(k) K852797
Substantially EquivalentMansfield Scientific, Inc.
FDA 510(k) clearance K852797 for HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE, Substantially Equivalent on 1985-09-16. Applicant: Mansfield Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Mansfield Scientific, Inc.
- Product code
- Code LDF
- Device class
- Class 2
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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More clearances from Mansfield Scientific, Inc.
view allAdverse events under product code LDF
product code LDF- Death
- 19
- Injury
- 188
- Malfunction
- 694
- Other
- 1
- Total
- 902
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.