FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A.V. FISTULA BLUNT NEEDLE SET
K Number: K082882
·
Decision Jan 21, 2009
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
10
Review Days
113
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Basic Information
- Device Name
- A.V. FISTULA BLUNT NEEDLE SET
- K Number
- K082882
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jms North America Corp.
- Date Received
- September 30, 2008
- Decision Date
- January 21, 2009
- 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 |
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Other Clearances by Jms North America Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K093637 | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 | Feb 9, 2010 | Substantially Equivalent |
| K070234 | JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS | May 22, 2007 | Substantially Equivalent |
| K070143 | JMS PLANECTA STOPCOCK | Apr 10, 2007 | Substantially Equivalent |
| K051814 | JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET | Aug 4, 2005 | Substantially Equivalent |
| K032975 | JMS BLOOD TUBING SETS | Aug 16, 2004 | Substantially Equivalent |
| K032977 | JMS BYPASS TUBE | May 25, 2004 | Substantially Equivalent |
| K040247 | PLUME SAFETY AVF NEEDLE | Mar 3, 2004 | Substantially Equivalent |
| K030479 | JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET | Aug 18, 2003 | Substantially Equivalent |
| K023668 | JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR | Jul 1, 2003 | Substantially Equivalent |