510(k) K083460 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
DIALOG WITH ADIMEA OPTION
| Applicant | B. Braun Avitum AG, Allentown PA, US |
| Decision | Substantially Equivalent, Feb 18, 2010 |
| Received | Nov 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083460
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2022 | B Braun Medical Inc Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts fo Terminated |
KDI | None listed |
| Jan 28, 2022 | B Braun Medical Inc Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts fo Terminated |
KDI | None listed |
| May 3, 2016 | B Braun Medical Inc Dialog+ Hemodialysis machines: Dialog A + HE/BIC
Product Code 710200L
Serial # >200318 and < 2039222
The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with a Terminated |
KDI | None listed |
| May 3, 2016 | B Braun Medical Inc Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V
Product Code 710200K
Serial # >202169 and < 203249
The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patie Terminated |
KDI | None listed |
| May 3, 2016 | B Braun Medical Inc Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL
Product Code # 710200S
Serial # >200805 and <204001
The Dialog+ can be used for implementing and monitoring hemodialysis treatments for Terminated |
KDI | None listed |
| May 3, 2016 | B Braun Medical Inc Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC
Product Code # 710200U
Serial # 202136 and < 203837
The Dialog+ can be used for implementing and monitoring hemodialysis treatments Terminated |
KDI | None listed |
| May 3, 2016 | B Braun Medical Inc Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A
The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failu Terminated |
KDI | None listed |
| May 3, 2016 | B Braun Medical Inc Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A
The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.