FDA product code OBJ: Catheter, Ultrasound, Intravascular
OBJ is the FDA product code for catheter, ultrasound, intravascular. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel. FDA has cleared 80 510(k) submissions under OBJ, 20 in the last five years, from 28 different applicants. The average 510(k) review took 92 days (median 71); 98 days on average over the last three years. FDA has posted 23 recalls for OBJ devices, 6 initiated in the last five years.
Definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Ultrasound, Intravascular |
| Device class | Class II |
| Regulation | 21 CFR 870.1200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for OBJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 59 |
| 2018 | 2 | 152 |
| 2019 | 1 | 57 |
| 2020 | 4 | 130 |
| 2021 | 3 | 102 |
| 2022 | 3 | 54 |
| 2023 | 3 | 59 |
| 2024 | 3 | 105 |
| 2025 | 7 | 89 |
| 2026 | 4 | 100 |
Compare with all 510(k) review times · Search every OBJ clearance
Top OBJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Volcano Corporation | 14 | 2016-10-26 |
| Siemens Medical Solutions USA, Inc. | 12 | 2026-09-10 |
| Biosense Webster, Inc. | 8 | 2024-06-28 |
| Boston Scientific Corporation | 8 | 2023-05-18 |
| Vasonova, Inc. | 5 | 2013-01-18 |
23 more applicants have OBJ clearances. See the full list in Caduvo.
Most recent OBJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261696 | Siemens Medical Solutions USA, Inc. | ACUNAV Luxera 4D ICE Catheter | 2026-09-10 | 111 |
| K261849 | Luma Vision Limited | VERAFEYE Imaging Catheter (VF-VIC-002) | 2026-07-24 | 51 |
| K252945 | Conavi Medical, Inc. | Novasight Hybrid System | 2026-04-17 | 214 |
| K260816 | Boston Scientific | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | 2026-04-08 | 26 |
| K253399 | Volcano Corporation (Dba Philips Image Guided Therapy Device | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | 2025-10-28 | 28 |
Recalls for OBJ devices
23 product recalls in 20 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 3 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code OBJ?
OBJ is the FDA product code for catheter, ultrasound, intravascular. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel.
What device class is OBJ?
Class II, regulation 21 CFR 870.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBJ?
Across 80 cleared submissions the average was 92 days from receipt to decision (median 71).
Which companies have the most OBJ clearances?
Volcano Corporation (14); Siemens Medical Solutions USA, Inc. (12); Biosense Webster, Inc. (8); Boston Scientific Corporation (8); Vasonova, Inc. (5).
Have OBJ devices been recalled?
Yes: 23 product recalls across 20 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code OBJ
- Run a recall and safety report across every OBJ manufacturer
- Watch product code OBJ 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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