FDA product code DXC: Clamp, Vascular
DXC is the FDA product code for clamp, vascular. It is a Class II device, regulated under 21 CFR 870.4450 and reviewed by the Cardiovascular panel. FDA has cleared 205 510(k) submissions under DXC, 12 in the last five years, from 127 different applicants. The average 510(k) review took 132 days (median 94); 171 days on average over the last three years. FDA has posted 26 recalls for DXC devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Vascular |
| Device class | Class II |
| Regulation | 21 CFR 870.4450 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 90 |
| 2018 | 2 | 42 |
| 2019 | 2 | 84 |
| 2020 | 3 | 197 |
| 2021 | 6 | 48 |
| 2022 | 1 | 82 |
| 2023 | 4 | 182 |
| 2024 | 1 | 146 |
| 2025 | 2 | 230 |
| 2026 | 4 | 136 |
Compare with all 510(k) review times · Search every DXC clearance
Top DXC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radi Medical Systems AB | 8 | 2008-02-26 |
| Cardiva Medical, Inc. | 7 | 2013-03-14 |
| Advanced Vascular Dynamics | 6 | 2015-07-31 |
| Novare Surgical Systems, Inc. | 6 | 2003-09-05 |
| Heartport, Inc. | 5 | 1997-04-04 |
122 more applicants have DXC clearances. See the full list in Caduvo.
Most recent DXC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262086 | Merit Medical Systems, Inc. | PreludeSYNC Radial Compression Device | 2026-07-22 | 30 |
| K260105 | Edwards Lifesciences | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | 2026-06-05 | 143 |
| K252772 | Tz Medical, Inc. | Arc Adjustable Radial Cuff Compression Device | 2026-05-22 | 262 |
| K254060 | TW Medical | Life Saving Tourniquet | 2026-04-03 | 107 |
| K243627 | Arc Trauma, LLC | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) | 2025-12-31 | 401 |
Recalls for DXC devices
26 product recalls in 17 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2025-08-15.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 4 |
Frequently asked questions
What is FDA product code DXC?
DXC is the FDA product code for clamp, vascular. It is a Class II device, regulated under 21 CFR 870.4450 and reviewed by the Cardiovascular panel.
What device class is DXC?
Class II, regulation 21 CFR 870.4450. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXC?
Across 205 cleared submissions the average was 132 days from receipt to decision (median 94).
Which companies have the most DXC clearances?
Radi Medical Systems AB (8); Cardiva Medical, Inc. (7); Advanced Vascular Dynamics (6); Novare Surgical Systems, Inc. (6); Heartport, Inc. (5).
Have DXC devices been recalled?
Yes: 26 product recalls across 17 recall events; the most recent began 2025-08-15.
Next steps
- Run an FDA pathway report with predicate devices for product code DXC
- Run a recall and safety report across every DXC manufacturer
- Watch product code DXC 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.
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