Panels › Cardiovascular › Product code PYX · Class 3
Temporary Non-Roller Type Right Heart Support Blood Pump
Regulation 870.4360
0510(k)s in 12 months (0 all time)
3recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in PYX
| Company | 510(k)s | Recalls |
|---|---|---|
| Abiomed, Inc. | 0 | 7 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2026 | Abiomed, Inc. Impella RP. Product Code: 0046-0011. Open, Classified |
PYX | None listed |
| Feb 27, 2026 | Abiomed, Inc. Impella RP Flex with SmartAssist. Product Code: 1000323. Open, Classified |
PYX | None listed |
| Feb 27, 2026 | Abiomed, Inc. Impella RP with SmartAssist. Product Code: 0046-0035. Open, Classified |
PYX | None listed |
| Jan 15, 2025 | Abiomed, Inc. Impella RP Flex with SmartAssist; Product Number: 1000323; Open, Classified |
PYX | None listed |
| Jan 15, 2025 | Abiomed, Inc. Impella RP with SmartAssist; Product Number: 0046-0035; Open, Classified |
PYX | None listed |
| Jan 4, 2024 | Abiomed, Inc. Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data. Open, Classified |
PYX | None listed |
| Aug 3, 2023 | Abiomed, Inc. Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323 Open, Classified |
PYX | None listed |
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