KAWASUMI LABORATORIES PHILEBOTOMY SET— 510(k) K994323
Substantially EquivalentKawasumi Laboratories Co., Ltd.
FDA 510(k) clearance K994323 for KAWASUMI LABORATORIES PHILEBOTOMY SET, Substantially Equivalent on 2000-03-08. Applicant: Kawasumi Laboratories Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Kawasumi Laboratories Co., Ltd.
- Product code
- Code LHI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code LHI
view allMore clearances from Kawasumi Laboratories Co., Ltd.
view all- 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
- K935506 — MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION
Adverse events under product code LHI
product code LHI- Injury
- 207
- Malfunction
- 7,820
- Other
- 3
- Total
- 8,030
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.