PERITONEAL CATHETER STABILIZATION DEVICE 5C4381— 510(k) K884554
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K884554 for PERITONEAL CATHETER STABILIZATION DEVICE 5C4381, Substantially Equivalent on 1989-01-31. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code FKX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
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Adverse events under product code FKX
product code FKX- Death
- 501
- Injury
- 6,720
- Malfunction
- 18,508
- Other
- 1
- Total
- 25,730
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.