FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
K-Shield Advantage Port Access Infusion Set (PAIS)
K Number: K190233
·
Decision May 2, 2019
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
11
Review Days
85
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Basic Information
- Device Name
- K-Shield Advantage Port Access Infusion Set (PAIS)
- K Number
- K190233
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kawasumi Laboratories, Inc.
- Date Received
- February 6, 2019
- Decision Date
- May 2, 2019
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Kawasumi Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | Jul 8, 2019 | Substantially Equivalent |
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Sep 28, 2018 | Substantially Equivalent |
| K123344 | K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) | Mar 7, 2013 | Substantially Equivalent |
| K100720 | K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING | Nov 18, 2010 | Substantially Equivalent |
| K102994 | K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR | Nov 3, 2010 | Substantially Equivalent |
| K073257 | KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR | Jan 25, 2008 | Substantially Equivalent |
| K061197 | KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER | Jun 30, 2006 | Substantially Equivalent |
| K060580 | K-SHIELD PORT ACCESS INFUSION SET | Jun 6, 2006 | Substantially Equivalent |
| K023917 | WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR | Feb 26, 2003 | Substantially Equivalent |
| K022110 | KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. | Sep 12, 2002 | Substantially Equivalent |