K-Shield Advantage Port Access Infusion Set (PAIS)— 510(k) K190233
Substantially EquivalentKawasumi Laboratories, Inc.
FDA 510(k) clearance K190233 for K-Shield Advantage Port Access Infusion Set (PAIS), Substantially Equivalent on 2019-05-02. Applicant: Kawasumi Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Kawasumi Laboratories, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tokyo, JP
Recent devices under product code FPA
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- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Kawasumi Laboratories, Inc.
view all- K190485 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
- 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
- K102994 — K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.