FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
K Number: K000845
·
Decision Apr 10, 2000
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
24
Review Days
26
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Basic Information
- Device Name
- MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
- K Number
- K000845
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jms Co., Ltd.
- Date Received
- March 15, 2000
- Decision Date
- April 10, 2000
- Product Code
- FIE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
JMS CAVEO A.V. Fistula Needle Set
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DORA Disposable A.V. Fistula Needle Sets
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Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
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JMS Harmony A.V. Fistula Needle Set
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ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
FDA 510(k)
FDA Class 2
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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 |
| 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 |