GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A— 510(k) K040301
UnknownGambro Renal Products
FDA 510(k) clearance K040301 for GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A, Unknown on 2004-11-01. Applicant: Gambro Renal Products. Device class: 2.
Clearance details
- Applicant
- Gambro Renal Products
- 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
- Lakewood, CO, US
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More clearances from Gambro Renal Products
view allAdverse 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.