FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
JMS APHERESIS NEEDLE SET ACCORDION TYPE
K Number: K002394
·
Decision Sep 5, 2001
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
24
Review Days
394
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Basic Information
- Device Name
- JMS APHERESIS NEEDLE SET ACCORDION TYPE
- K Number
- K002394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jms Co., Ltd.
- Date Received
- August 7, 2000
- Decision Date
- September 5, 2001
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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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 |
| 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 |
| K974902 | JMS APHERESIS NEEDLE | Mar 30, 1998 | Substantially Equivalent |