TEMP. PERVENOUS LEAD W/REMOTE ANODE— 510(k) K770214
Substantially EquivalentCordis Corp.
FDA 510(k) clearance K770214 for TEMP. PERVENOUS LEAD W/REMOTE ANODE, Substantially Equivalent on 1977-03-28. Applicant: Cordis Corp.. Device class: 3.
Clearance details
- Applicant
- Cordis Corp.
- Product code
- Code DTB
- Device class
- Class 3
- Regulation
- 21 CFR 870.3680
- 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 DTB
product code DTB- Death
- 1,491
- Injury
- 67,311
- Malfunction
- 79,368
- Other
- 10
- Total
- 148,180
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.