MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM— 510(k) K983023

Substantially Equivalent

Cordis 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..

Clearance details

Applicant: Cordis Corp.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 1998-08-31
Decision date: 1998-10-01
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, 2020-01-01 through 2026-04-23. 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.