NEXT GENERATION SALEM SUMP— 510(k) K040388
Substantially EquivalentKendall
FDA 510(k) clearance K040388 for NEXT GENERATION SALEM SUMP, Substantially Equivalent on 2004-05-17. Applicant: Kendall. Device class: 2.
Clearance details
- Applicant
- Kendall
- Product code
- Code FEG
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code FEG
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- K051584 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
- K043272 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
Adverse events under product code FEG
product code FEG- Death
- 2
- Total
- 2
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.