MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM— 510(k) K983023
Substantially EquivalentCordis Corp.
FDA 510(k) clearance K983023 for MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM, Substantially Equivalent on 1998-10-01. Applicant: Cordis Corp.. Device class: 2.
Clearance details
- Applicant
- Cordis Corp.
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Miami Lakes, FL, US
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Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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.