FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
K Number: K061197
·
Decision Jun 30, 2006
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
11
Review Days
63
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Basic Information
- Device Name
- KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
- K Number
- K061197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kawasumi Laboratories, Inc.
- Date Received
- April 28, 2006
- Decision Date
- June 30, 2006
- Product Code
- KPE
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | 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 |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) | May 2, 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 |
| 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 |