FDA product code DYG: Catheter, Flow Directed
DYG is the FDA product code for catheter, flow directed. It is a Class II device, regulated under 21 CFR 870.1240 and reviewed by the Cardiovascular panel. FDA has cleared 99 510(k) submissions under DYG, 5 in the last five years, from 54 different applicants. The average 510(k) review took 107 days (median 77); 165 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 49 recalls for DYG devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Flow Directed |
| Device class | Class II |
| Regulation | 21 CFR 870.1240 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DYG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 62 |
| 2022 | 1 | 144 |
| 2023 | 1 | 143 |
| 2024 | 3 | 165 |
Top DYG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 7 | 2000-07-07 |
| Nova Medical Specialties | 7 | 1987-10-15 |
| American Edwards Laboratories | 6 | 1982-10-15 |
| Medtronic Vascular | 4 | 2001-08-28 |
| J-Lloyd Medical, Inc. | 4 | 1997-02-03 |
49 more applicants have DYG clearances. See the full list in Caduvo.
Most recent DYG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242451 | Edwards Lifesciences | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | 2024-12-09 | 115 |
| K233983 | Edwards Lifesciences | 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) | 2024-06-27 | 192 |
| K233824 | Edwards Lifesciences, LLC | Swan-Ganz catheter | 2024-06-06 | 188 |
| K231248 | Edwards Lifesciencess, LLC | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | 2023-09-21 | 143 |
| K222117 | Edwards Lifesiences, LLC | Swang-Ganz IQ pulmonary artery catheter | 2022-12-09 | 144 |
Recalls for DYG devices
49 product recalls in 14 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-04-08.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2019 | 2 |
| 2023 | 2 |
| 2025 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code DYG?
DYG is the FDA product code for catheter, flow directed. It is a Class II device, regulated under 21 CFR 870.1240 and reviewed by the Cardiovascular panel.
What device class is DYG?
Class II, regulation 21 CFR 870.1240. Typical premarket route: 510(k).
How long does a 510(k) take for product code DYG?
Across 99 cleared submissions the average was 107 days from receipt to decision (median 77).
Which companies have the most DYG clearances?
Baxter Healthcare Corp (7); Nova Medical Specialties (7); American Edwards Laboratories (6); Medtronic Vascular (4); J-Lloyd Medical, Inc. (4).
Have DYG devices been recalled?
Yes: 49 product recalls across 14 recall events; the most recent began 2026-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code DYG
- Run a recall and safety report across every DYG manufacturer
- Watch product code DYG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.