FDA product code PSQ: Intracardiac Patch Or Pledget, Biologically Derived
PSQ is the FDA product code for intracardiac patch or pledget, biologically derived. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel. FDA has cleared 11 510(k) submissions under PSQ, 2 in the last five years, from 8 different applicants. The average 510(k) review took 152 days (median 147). FDA has posted 2 recalls for PSQ devices, 2 initiated in the last five years.
Definition
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Classification
| Field | Value |
|---|---|
| Device name | Intracardiac Patch Or Pledget, Biologically Derived |
| Device class | Class II |
| Regulation | 21 CFR 870.3470 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PSQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 82 |
| 2018 | 1 | 174 |
| 2019 | 2 | 98 |
| 2020 | 2 | 172 |
| 2021 | 1 | 319 |
| 2022 | 2 | 195 |
Compare with all 510(k) review times · Search every PSQ clearance
Top PSQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synovis Life Technologies, Inc. | 2 | 2022-10-19 |
| Admedus Regen Pty, Ltd. | 2 | 2020-04-03 |
| Cryolife, Inc. | 2 | 2019-02-14 |
| Helios Cardio, Inc. | 1 | 2021-12-21 |
| Lemaitre Vascular | 1 | 2020-02-13 |
3 more applicants have PSQ clearances. See the full list in Caduvo.
Most recent PSQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221029 | Synovis Life Technologies, Inc. | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | 2022-10-19 | 195 |
| K221032 | Synovis Life Technologies, Inc. | Vascu-Guard Vascular Repair Patch | 2022-10-19 | 195 |
| K210331 | Helios Cardio, Inc. | CardiaMend Pericardial and Epicardial Reconstruction Matrix | 2021-12-21 | 319 |
| K200566 | Admedus Regen Pty, Ltd. | ADAPT Tissue | 2020-04-03 | 30 |
| K190882 | Lemaitre Vascular | XenoSure Biologic Patch | 2020-02-13 | 315 |
Recalls for PSQ devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-12-06.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code PSQ?
PSQ is the FDA product code for intracardiac patch or pledget, biologically derived. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel.
What device class is PSQ?
Class II, regulation 21 CFR 870.3470. Typical premarket route: 510(k).
How long does a 510(k) take for product code PSQ?
Across 11 cleared submissions the average was 152 days from receipt to decision (median 147).
Which companies have the most PSQ clearances?
Synovis Life Technologies, Inc. (2); Admedus Regen Pty, Ltd. (2); Cryolife, Inc. (2); Helios Cardio, Inc. (1); Lemaitre Vascular (1).
Have PSQ devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2023-12-06.
Next steps
- Run an FDA pathway report with predicate devices for product code PSQ
- Run a recall and safety report across every PSQ manufacturer
- Watch product code PSQ 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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