FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Kawasumi Laboratories Blood Drawing Kit (BDK) System
K Number: K172957
·
Decision Sep 28, 2018
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
5
Applicant Total
11
Review Days
367
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Basic Information
- Device Name
- Kawasumi Laboratories Blood Drawing Kit (BDK) System
- K Number
- K172957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9875
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kawasumi Laboratories, Inc.
- Date Received
- September 26, 2017
- Decision Date
- September 28, 2018
- Product Code
- KSB
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KSB | Set, Transfer (Blood/Plasma) | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KSB), ordered by most recent decision date.
KAWASUMI LABORATORY BLOOD DRAWING KIT
FDA 510(k)
FDA Class 2
·Hematology
ALPHA PLASMA TRANSFER SET
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·Hematology
SUPER-SPIKE TRANSFER SET
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·Hematology
FLU-VEN TK-2
FDA 510(k)
FDA Class 2
·Hematology
FLU VEN TR-1
FDA 510(k)
FDA Class 2
·Hematology
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 |
| 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 |