KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.— 510(k) K022110
Substantially EquivalentKawasumi Laboratories, Inc.
FDA 510(k) clearance K022110 for KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS., Substantially Equivalent on 2002-09-12. Applicant: Kawasumi Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Kawasumi Laboratories, Inc.
- 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
- Washington, DC, US
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More clearances from Kawasumi Laboratories, Inc.
view all- K190485 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
- K190233 — K-Shield Advantage Port Access Infusion Set (PAIS)
- K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) System
- K123344 — K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
- K100720 — K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING
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.