Submission Details
| 510(k) Number | K123351 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 2012 |
| Decision Date | March 19, 2013 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
Mar 2013
Decision
139d
Days
Class 2
Risk
About This 510(k) Submission
K123351 is an FDA 510(k) clearance for the AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on March 19, 2013, 139 days after receiving the submission on October 31, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.
Device Classification
| Product Code | DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4260 |
Manufacturer
Similar Devices — DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
All 95
K251744 · Medtronic
· Jan 2026
K242953 · Sorin Group Italia S.R.L.
· Dec 2024
K242092 · Sorin Group Italia S.R.L.
· Nov 2024
K231362 · TransMedics, Inc.
· Oct 2023
K122760 · Medtronic, Inc.
· Dec 2012
K121209 · Terumo Cardiovascular Systems Corporation
· May 2012
More from Medtronic Perfusion Systems
View all
K240666
· DTZ · Jul 2024
K181954
· CAC · Aug 2018
K101186
· DTP · Sep 2010
K090869
· DWF · Aug 2009
K080824
· DWA · May 2008