STANICOR THETA MODEL 221 CARDIAC PACER— 510(k) K780453
Substantially EquivalentCordis Corp.
FDA 510(k) clearance K780453 for STANICOR THETA MODEL 221 CARDIAC PACER, Substantially Equivalent on 1978-06-30. Applicant: Cordis Corp.. Device class: 3.
Clearance details
- Applicant
- Cordis Corp.
- Product code
- Code DXY
- Device class
- Class 3
- Regulation
- 21 CFR 870.3610
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code DXY
product code DXY- Death
- 240
- Injury
- 2,328
- Malfunction
- 2,096
- Total
- 4,664
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.