INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX— 510(k) K002847

Substantially Equivalent

Maxxim Medical

FDA 510(k) clearance K002847 for INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX, Substantially Equivalent on 2001-05-31. Applicant: Maxxim Medical.

Clearance details

Applicant: Maxxim Medical
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2000-09-13
Decision date: 2001-05-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Athens, TX, US

Download summary PDF View on FDA.gov ↗

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.