OXY-1 System
FDA 510(k) clearance K223161 · decided 2023-02-23
Clearance details
- K-number
- K223161
- Device name
- OXY-1 System
- Applicant
- Abiomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-10-07
- Decision date
- 2023-02-23
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Impella CP with SmartAssist; Impella 5.5 with SmartAssist (P140003/S136) | Abiomed, Inc. | 2025-12-19 |
| Impella CP with SmartAssist; Impella 5.5 with SmartAssist (P170011/S062) | Abiomed, Inc. | 2025-12-19 |
| Impella 5.5 with SmartAssist (P140003/S131) | Abiomed, Inc. | 2025-10-01 |
| Impella CP with SmartAssist (P140003/S130) | Abiomed, Inc. | 2025-09-24 |
| Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD (P140003/S129) | Abiomed, Inc. | 2025-09-19 |
| Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist (P170011/S060) | Abiomed, Inc. | 2025-09-19 |
| Purge Cassette (P170011/S058) | Abiomed, Inc. | 2025-09-15 |
| Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette (P140003/S126) | Abiomed, Inc. | 2025-09-15 |