510(k) · Cleared
Cleared15 FR. Tandemheart Arterial Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiacassist, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Feb 12, 2014 as substantially equivalent to K120543 (Cardiacassist, Inc., 2012) and 1 other predicate after a 110-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Feb 12, 2014
- Review
- 110 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924642 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120543 | Tandemheart Femoral Arterial Cannula SetSummary page 1…catheter, cannula, or tubing. (21 CFR 870.4210, Product Code DWF) Predicate Devices 17 French TandemHeart Femoral Arterial Cannula Set (K 120543) Medtronic Bio-Medicus Femoral Cannula and Introducer (K924642) Device Description The 15 French TandemHeart Femoral Arterial… | 2012 |
| * | K924642 | Medtronic Bio-Medicus Femoral Cannula/IntroducerSummary page 1…FR 870.4210, Product Code DWF) Predicate Devices 17 French TandemHeart Femoral Arterial Cannula Set (K 120543) Medtronic Bio-Medicus Femoral Cannula and Introducer (K924642) Device Description The 15 French TandemHeart Femoral Arterial Cannula Set consists of two components, as shown in Figure 1:… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 19.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
The 15 French TandemHeart Arterial Cannula Set (15 Fr. THAC) is intended to
cannulate vessels, perfuse vessels or organs and/or connect with accessory
extracorporeal circulatory support equipment. The cannula introducer is intended to
facilitate proper insertion and placement of the cannula within the vessel for
extracorporeal circulatory support. These devices are to be used by a trained physician
only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133293: 15 FR. Tandemheart Arterial Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133293
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026