PORT ACCESS NEEDLE— 510(k) K921902
Substantially EquivalentKawasumi Laboratories Co., Ltd.
FDA 510(k) clearance K921902 for PORT ACCESS NEEDLE, Substantially Equivalent on 1993-07-28. Applicant: Kawasumi Laboratories Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Kawasumi Laboratories Co., Ltd.
- Product code
- Code LJT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5965
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
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- K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more
More clearances from Kawasumi Laboratories Co., Ltd.
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 LJT
product code LJT- Death
- 234
- Injury
- 6,468
- Malfunction
- 5,326
- Other
- 2
- Total
- 12,030
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.