JMS Sysloc Mini Avf and Apheresis Needle Sets
FDA 510(k) K070234 · Jms North America Corp.
510(k) numberK070234
Submission
- Device name
- JMS Sysloc Mini Avf and Apheresis Needle Sets
- Applicant
- Jms North America Corp.
Hayward, CA, US - Received
- January 16, 2007
- Decision date
- May 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MPB – Catheter, Hemodialysis, Non-Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code MPB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen CatheterMPB · Traditional | Medical Components, Inc. | 08/12/2025SE |
| K200426 | Acute Dual Lumen Hemodialysis CatheterMPB · Traditional | Health Line International Corporation | 12/24/2020SESK |
| K192807 | Duo-Flow Side x Side Double Lumen CatheterMPB · Traditional | Medical Components, Inc. (dba MedComp) | 04/23/2020SE |
| K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…MPB · Traditional | Covidien, LLC | 01/17/2020SEKD |
| K163458 | Zenysis Short-Term Dialysis CatheterMPB · Traditional | C.R. Bard, Inc. | 04/04/2017SEKD |
| K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayMPB · Special | Cook Incorporated | 01/06/2017SEKD |
| K153190 | Zenysis Short-Term Dialysis CatheterMPB · Traditional | C.R. Bard, Inc. | 01/05/2016SE |
| K122091 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute…MPB · Traditional | Cook, Inc. | 07/29/2013SESK |
| K120674 | Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterMPB · Special | Covidien | 04/04/2012SESK |
| K110793 | Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization KitsMPB · Traditional | Ameco Medical Industries | 12/16/2011SE |
More from Ameco Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K251877 | JMS CAVEO A.V. Fistula Needle SetFIE · Traditional | 08/15/2025SE |
| K172499 | NeoshieldONB · Traditional | 06/01/2018SE |
| K151017 | JMS Harmony A.V. Fistula Needle SetFIE · Special | 05/13/2015SE |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)FIE · Special | 12/23/2014SE |
| K132321 | JMS SyringeFMF · Traditional | 02/20/2014SE |
| K121488 | JMS Safe Wing Cath (SWC)FOZ · Traditional | 03/05/2013SE |
| K112178 | JMS Apheresis Needle Set Wingeater(R) V2FIE · Special | 10/27/2011SE |
| K111948 | Wingeater V2FIE · Special | 10/24/2011SE |
| K110157 | Sysloc Mini V3FIE · Special | 02/11/2011SE |
| K093637 | JMS Blunt A. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…FIE · Traditional | 02/09/2010SE |
Questions and answers
When was JMS Sysloc Mini Avf and Apheresis Needle Sets cleared by the FDA?
JMS Sysloc Mini Avf and Apheresis Needle Sets (K070234) received a 510(k) decision of Substantially Equivalent on May 22, 2007, 126 days after the submission was received.
What is the product code of K070234?
The FDA product code is MPB – Catheter, Hemodialysis, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.