510(k) · Cleared
ClearedPeak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surge Cardiovascular · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Aug 10, 2017 as substantially equivalent to K964194 (Chase Medical, Inc., 1997) and 2 other predicates after a 174-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- Aug 10, 2017
- Review
- 174 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K770430 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K770430 | Catheter, Curved Left Heart Vent | 3M Health Care, Sarns | 1977 | — |
| −1 | K964194 | Chase Curved Left Heart Vent Catheter | Chase Medical, Inc. | 1997 | — |
| 0 (this device) | K170488 | Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent… | Surge Cardiovascular | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K964194 | Chase Curved Left Heart Vent CatheterSummary page 4…DWF Class: II III. PREDICATE DEVICE Primary Predicate Device Curved Left Heart Vent Catheter, K0964194 Secondary Predicate Devices DLP Left Heart Vent Catheter, K834352 Malleable Vent Catheter, K981601… | 1997 |
| * | K834352 | Adult Vent CatheterSummary page 4…ATE DEVICE Primary Predicate Device Curved Left Heart Vent Catheter, K0964194 Secondary Predicate Devices DLP Left Heart Vent Catheter, K834352 Malleable Vent Catheter, K981601 This predicate devices have not been subject to a recall. K170488 Surge Car… | 1984 |
| * | K981601 | California Medical Laboratories Inc. Malleable Vent CatheterSummary page 4…ice Curved Left Heart Vent Catheter, K0964194 Secondary Predicate Devices DLP Left Heart Vent Catheter, K834352 Malleable Vent Catheter, K981601 This predicate devices have not been subject to a recall. K170488 Surge Cardiovascular Left Ventricular Vent… | 1998 |
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 40 years and passes through 3 companies; a new generation was cleared every 20.3 years on median.
- 1 of the 4 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. 2017, 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 Peak Left Ventricular Vent Cannula is indicated for use in venting the left ventricle during cardiopulmonary bypass procedures for durations up to 6 hours. The entrance is made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.
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/K170488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170488: Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170488
Report an extraction error
Are you the manufacturer?
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