FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
JMS TRANSFUSION SET
K Number: K880174
·
Decision Feb 16, 1988
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
29
Applicant Total
24
Review Days
32
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Basic Information
- Device Name
- JMS TRANSFUSION SET
- K Number
- K880174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Jms Co., Ltd.
- Date Received
- January 15, 1988
- Decision Date
- February 16, 1988
- Product Code
- BRZ
- 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 |
|---|---|---|---|
| BRZ | Set, Blood Transfusion | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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PENTATRASFU BLOOD TRANSFUSION SETS
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Other Clearances by Jms Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K002352 | JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE | Sep 6, 2001 | Substantially Equivalent |
| K002394 | JMS APHERESIS NEEDLE SET ACCORDION TYPE | Sep 5, 2001 | Substantially Equivalent |
| K010406 | JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G | Jun 20, 2001 | Substantially Equivalent |
| K010410 | JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G | Jun 20, 2001 | Substantially Equivalent |
| K000845 | MODIFICATION TO JMS A.V. FISTULA NEEDLE SET | Apr 10, 2000 | Substantially Equivalent |
| K000843 | MODIFICATION TO JMS APHERESIS NEEDLE | Apr 10, 2000 | Substantially Equivalent |
| K991904 | MODIFICATION OF JMS NEEDLES AND JMS SYRINGES | Aug 31, 1999 | Substantially Equivalent |
| K990470 | JMS A. V. FISTULA NEEDLE SET | Aug 30, 1999 | Substantially Equivalent |
| K990510 | JMS APHERESIS NEEDLE | Aug 30, 1999 | Substantially Equivalent |
| K983707 | JMS DIALYZER PRIMING SET | Jan 8, 1999 | Substantially Equivalent |