COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY— 510(k) K122091
UnknownCook, Inc.
FDA 510(k) clearance K122091 for COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY, Unknown on 2013-07-29. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- Product code
- Code MPB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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Adverse events under product code MPB
product code MPB- Death
- 18
- Malfunction
- 1,042
- Total
- 1,060
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.