POLYSTAN HEART LUNG MACHINE SYS
FDA 510(k) clearance K813034 · decided 1981-11-27
Clearance details
- K-number
- K813034
- Device name
- POLYSTAN HEART LUNG MACHINE SYS
- Applicant
- Advocacy International, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-28
- Decision date
- 1981-11-27
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- DTQ
- Device class
- 2
- Regulation number
- 870.4220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Essenz HLM, Essenz ILBM (K232291) | Livanova Deutschland, GmbH | 2023-08-24 |
| Terumo Advanced Perfusion System 1 (K221895) | Terumo Cardiovascular Systems Corporation | 2023-04-18 |
| Essenz HLM (K221373) | Livanova Deutschland, GmbH | 2023-03-09 |
| Stockert S5 System (K210130) | Livanova Deutschland, GmbH | 2021-04-05 |
| Century Perfusion System (K202125) | Century Hlm, LLC | 2021-03-07 |
| Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (K190282) | Spectrum Medical , Ltd. | 2019-05-24 |
| Quantum Pump Console (K173834) | Spectrum Medical , Ltd. | 2018-05-25 |
| Advanced Perfusion System 1 (K172220) | Terumo Cardiovascular Systems Corporation | 2017-08-17 |
| Advanced Perfusion System 1 (K163531) | Terumo Cardiovascular Systems Corporation | 2017-06-07 |
| Advanced Perfusion System 1 (K153376) | Terumo Cardiovascular Systems Corporation | 2015-12-16 |
| Advanced Perfusion System 1 (K151349) | Terumo Cardiovascular Systems Corporation | 2015-08-27 |
| CARDIOHELP SYSTEM (K133598) | Maquet Cardiopulmonary, AG | 2014-05-21 |
Recalls involving this device
No recalls on record reference this clearance.