KOC — Accessories, Blood Circuit, Hemodialysis Class II
FDA Device Classification
Classification Details
- Product Code
- KOC
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K242176 | nikkiso co | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR | May 15, 2025 |
| K242479 | nikkiso co | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR | May 15, 2025 |
| K231589 | nikkiso co | Blood Tubing Lines for Hemodialysis AV06C-E | July 28, 2023 |
| K230514 | nikkiso co | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for | June 16, 2023 |
| K201207 | fresenius medical care renal therapies group | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and In | September 18, 2020 |
| K172238 | fresenius medical care renal therapies group | CAREline Airless Hemodialysis Blood Tubing Sets | December 14, 2017 |
| K160749 | fresenius medical care renal therapies group | CRIT-LINE III Blood Chamber II | April 15, 2016 |
| K152953 | fresenius medical care north america | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | November 5, 2015 |
| K141997 | fresenius medical care | CRIT-LINE IV SYSTEM | April 1, 2015 |
| K141281 | fresenius medical care renal therapies group | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | August 14, 2014 |
| K121599 | fresenius medical care-north america | CRIT-LINE CLIP (CLIC) | November 9, 2012 |
| K082719 | nikkiso co | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, | March 30, 2009 |
| K081740 | innovations for access | HEMOBAND, MODELS HB-NS AND HB-NSXL | March 12, 2009 |
| K082758 | stihler electronic | PRISMAFLO II | December 19, 2008 |
| K081043 | nxstage medical | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | July 7, 2008 |
| K071909 | barkey gmbh and co. kg | PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R | October 18, 2007 |
| K030456 | vasc-alert | VASC-ALERT | July 11, 2003 |
| K022536 | fresenius medical care | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RES | October 30, 2002 |
| K020103 | stihler electronic | PRISMAFLO | July 24, 2002 |
| K003712 | molded products | MODIFICATION TO MALE TO MALE LUER ADAPTER | May 16, 2001 |