FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAWASUMI LABORATORIES PHILEBOTOMY SET
K Number: K994323
·
Decision Mar 8, 2000
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
18
Review Days
77
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Basic Information
- Device Name
- KAWASUMI LABORATORIES PHILEBOTOMY SET
- K Number
- K994323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kawasumi Laboratories Co., Ltd.
- Date Received
- December 22, 1999
- Decision Date
- March 8, 2000
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Kawasumi Laboratories Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K974829 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) | Feb 12, 1998 | Substantially Equivalent |
| K964117 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE | Mar 14, 1997 | Substantially Equivalent |
| K935514 | VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER | Feb 10, 1994 | Substantially Equivalent |
| K935506 | MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION | Feb 3, 1994 | Substantially Equivalent |
| K935505 | WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER | Feb 3, 1994 | Substantially Equivalent |
| K930012 | KAWASUMI LABORATORIES K-CUFF | Dec 14, 1993 | Substantially Equivalent |
| K921901 | PORT ACCESS INFUSION SET | Sep 10, 1993 | Substantially Equivalent |
| K921902 | PORT ACCESS NEEDLE | Jul 28, 1993 | Substantially Equivalent |
| K923323 | INTERMITTENT INJECTION SITE | Jul 13, 1993 | Substantially Equivalent |
| K896892 | KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET | Sep 12, 1990 | Substantially Equivalent |