FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JMS SAFE WING CATH (SWC)
K Number: K121488
·
Decision Mar 5, 2013
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
9
Review Days
291
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Basic Information
- Device Name
- JMS SAFE WING CATH (SWC)
- K Number
- K121488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JMS North America Corporation
- Date Received
- May 18, 2012
- Decision Date
- March 5, 2013
- Product Code
- FOZ
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by JMS North America Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251877 | JMS CAVEO A.V. Fistula Needle Set | Aug 15, 2025 | Substantially Equivalent |
| K172499 | NEOSHIELD | Jun 1, 2018 | Substantially Equivalent |
| K151017 | JMS Harmony A.V. Fistula Needle Set | May 13, 2015 | Substantially Equivalent |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | Dec 23, 2014 | Substantially Equivalent |
| K132321 | JMS SYRINGE | Feb 20, 2014 | Substantially Equivalent |
| K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | Oct 27, 2011 | Substantially Equivalent |
| K111948 | WINGEATER V2 | Oct 24, 2011 | Substantially Equivalent |
| K110157 | SYSLOC MINI V3 | Feb 11, 2011 | Substantially Equivalent |