INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX— 510(k) K002847
Substantially EquivalentMaxxim 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. Device class: 2.
Clearance details
- Applicant
- Maxxim Medical
- 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
- Abbreviated
- Location
- Athens, TX, 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.