510(k) · Cleared
ClearedChase Aortic Perfusion Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chase Medical, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on May 13, 1997 as substantially equivalent to K770429 (3M Health Care, Sarns, 1977) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- May 13, 1997
- Review
- 62 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K770429 (1977). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK770429 Cannulae, Aortic, Arch, High Flow3M Health Care, Sarns · 1977 · Recalled
- This deviceK970914 Chase Aortic Perfusion CannulaChase Medical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770429 | Cannulae, Aortic, Arch, High Flow | 3M Health Care, Sarns | 1977 | 12 |
| 0 (this device) | K970914 | Chase Aortic Perfusion Cannula | Chase Medical, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K770429 | Cannulae, Aortic, Arch, High FlowSummary page 1…ssification: Class Il device Safety and Effectiveness: Substantial Equivalence: This device is substantially equivalent to the combination of Sarns Aortic Arch Cannula (K770429), DLP Aortic Root Cannula (K790565), and an aortic cross clamp. Other Safety and Effectiveness Data: Materials: All materials a… | 1977 |
| * | K790565 | Aortic Root CannulaSummary page 1…y and Effectiveness: Substantial Equivalence: This device is substantially equivalent to the combination of Sarns Aortic Arch Cannula (K770429), DLP Aortic Root Cannula (K790565), and an aortic cross clamp. Other Safety and Effectiveness Data: Materials: All materials are identical to materials used in s… | 1979 |
| * | — | aortic cross clamp Named without a submission number |
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?
- 2 of the 2 ancestors have a recall of any class.
- 4 other devices also cite its predicate K770429.
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.
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 Aortic Perfusion Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass. Additionally, the Aortic Perfusion Cannula can be used to occlude the ascending aorta as well as deliver cardioplegia solution to and aspirate air from the aorta.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970914: Chase Aortic Perfusion Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970914
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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