MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS— 510(k) K981365
Substantially EquivalentSherwood Medical Co.
FDA 510(k) clearance K981365 for MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS, Substantially Equivalent on 1998-11-25. Applicant: Sherwood Medical Co.. Device class: 2.
Clearance details
- Applicant
- Sherwood Medical Co.
- Product code
- Code MSD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
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Adverse events under product code MSD
product code MSD- Death
- 67
- Injury
- 545
- Malfunction
- 3,661
- Total
- 4,273
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.