RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS— 510(k) K883748
Substantially EquivalentKawasumi Laboratories Co., Ltd.
FDA 510(k) clearance K883748 for RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS, Substantially Equivalent on 1989-01-31. Applicant: Kawasumi Laboratories Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Kawasumi Laboratories Co., Ltd.
- Product code
- Code FJI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code FJI
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view all- K994323 — KAWASUMI LABORATORIES PHILEBOTOMY SET
- K974829 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
- K964117 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
- K935514 — VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER
- K935505 — WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER
Adverse events under product code FJI
product code FJI- 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.