510(k) · Cleared
Recalled · Class II · 2026Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences · DYG Catheter, Flow Directed
Cleared on Jun 27, 2024 as substantially equivalent to K791183 (Edwards Lifesciences, LLC, 1979) and 2 other predicates after a 192-day review. Its family tree reaches back 2 generations to 1982. It has been recalled once.
- Decided
- Jun 27, 2024
- Review
- 192 days
- Class
- Class II
- Product code
- DYG
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K813521 (1982). 4 ancestors in all, the oldest K791183 (1979). No later device cites it as a predicate yet.
- Root · 2 generations backK813521 Transluminal Bipolar Pacing ProbeAmerican Edwards Laboratories · 1982
- 1 generation backK152633 Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal…Edwards Lifesciences, LLC · 2015
- This deviceK233983 Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing…Edwards Lifesciences · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813521 | Transluminal Bipolar Pacing Probe | American Edwards Laboratories | 1982 | — |
| −1 | K152633 | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar… | Edwards Lifesciences, LLC | 2015 | — |
| 0 (this device) | K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter… | Edwards Lifesciences | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 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 DYG? 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 DYG device
- #1 K242451 HemoSphere Alta Advanced Monitoring Platform…score 24.2 · 39 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 |
|---|---|---|---|
| * | K791183 | Swan-Ganz Flow-Directed CatheterSummary page 5…Cardiovascular permanent or temporary pacemaker electrode Regulation Class Class II Swan-Ganz Flow Directed Catheter (K791183, cleared on July 12, 1979) Predicate Device Swan-Ganz Bipolar Pacing Catheter (K822723, cleared on… | 1979 |
| * | K822723 | Swan-Ganz Bipolar Pacing CatheterSummary page 5…-Ganz Flow Directed Catheter (K791183, cleared on July 12, 1979) Predicate Device Swan-Ganz Bipolar Pacing Catheter (K822723, cleared on Oct 15, 1982) Chandler Transluminal Bipolar Pacing Probe (K152633, clea… | 1982 |
| * | K152633 | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing ProbeSummary page 5…polar Pacing Catheter (K822723, cleared on Oct 15, 1982) Chandler Transluminal Bipolar Pacing Probe (K152633, cleared Oct 15, 2015) The Swan-Ganz Pacing Catheters and Pacing Probes are a series of… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2026 | Class II | Z-2204-2026 | Process change control | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 3 companies; a new generation was cleared every 33.6 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DYG devicesDYG Catheter, Flow Directed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DYG
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DYG
188in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYG
2in 2019
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DYG
268in 2025
MAUDE reports naming product code DYG, 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 | 0 | — | 1 | 168 |
| 2008 | 1 | — | 0 | 400 |
| 2009 | 0 | — | 3 | 145 |
| 2010 | 0 | — | 0 | 147 |
| 2011 | 1 | — | 0 | 249 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 149 |
| 2014 | 0 | — | 0 | 178 |
| 2015 | 0 | — | 0 | 163 |
| 2016 | 1 | — | 0 | 154 |
| 2017 | 0 | — | 0 | 115 |
| 2018 | 0 | — | 4 (4) | 133 |
| 2019 | 0 | — | 2 | 144 |
| 2020 | 1 | — | 0 | 104 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 0 | 130 |
| 2023 | 1 | — | 0 | 229 |
| 2024 | 3 | 188 | 0 | 226 |
| 2025 | 0 | — | 0 | 268 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Swan-Ganz pacing-TD catheters are indicated for use for temporary, atrial, ventricular, or A-V sequential cardiac pacing of adult surgical and/or critically ill patients. This includes, but is not limited to, patients with arrythmias, acute myocardial infarction, cardiac surgery, and coronary angiography. In addition, these catheters are indicated for use in hemodynamic monitoring of patients experiencing medical conditions such as, but not limited…
Read the full statement (156 words)
The Swan-Ganz pacing-TD catheters are indicated for use for temporary, atrial, ventricular, or A-V sequential cardiac pacing of adult surgical and/or critically ill patients. This includes, but is not limited to, patients with arrythmias, acute myocardial infarction, cardiac surgery, and coronary angiography. In addition, these catheters are indicated for use in hemodynamic monitoring of patients experiencing medical conditions such as, but not limited to, post-major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, stroke, and cardiac disease including heart failure.
The Swan-Ganz bipolar pacing catheters are indicated for use in surgical and/or critically ill cardiac patients who may benefit from temporary, transvenous right ventricular pacing.
The Chandler transluminal V-pacing probe is a transluminal bipolar pacing probe, which must be used with a Swan-Ganz Paceport catheter is indicated for use in adult surgical and/or critically ill cardiac patients. This includes, but is not limited to, patients with arrhythmias, acute myocardial infarction, cardiac surgery and coronary angiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233983: Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233983
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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