Cardiacassist, Inc.
Pittsburgh, PA, US
Cardiacassist, Inc. appears in FDA device records in Pittsburgh, PA. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Cardiacassist, Inc. between 2000 and 2024. The busiest year on record is 2014, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2003 | 1 |
| 2006 | 2 |
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 3 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233736 | LifeSPARC System | QNR | Substantially Equivalent | |
| K232480 | ProtekDuo Veno-Venous Cannula Sets | PZS | Substantially Equivalent | |
| K232132 | LifeSPARC System | KFM | Substantially Equivalent | |
| K211830 | LifeSPARC System | QNR | Substantially Equivalent | |
| K202751 | TandemHeart Pump and Escort Controller | QNR | Substantially Equivalent | |
| K183623 | LifeSPARC Pump, LifeSPARC Controller | KFM | Substantially Equivalent | |
| K181150 | ProtekDuo Mini Veno-Venous Cannula Set | DWF | Substantially Equivalent | |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | DRE | Substantially Equivalent | |
| K162214 | Protek Solo 24 Fr Venous Cannula Set | DWF | Substantially Equivalent | |
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set | DWF | Substantially Equivalent | |
| K153295 | TandemLung Oxygenator | DTZ | Substantially Equivalent | |
| K140999 | TANDEMHEART VENO-VENOUS CANNULA | DWF | Substantially Equivalent | |
| K133293 | 15 FR. TANDEMHEART ARTERIAL CANNULA | DWF | Substantially Equivalent | |
| K133236 | TANDEMHEART FEMORAL VENOUS CANNULA SET | DWF | Substantially Equivalent | |
| K120543 | TANDEMHEART FEMORAL ARTERIAL CANNULA SET | DWF | Substantially Equivalent | |
| K110493 | TANDEMHEART PUMP | KFM | Substantially Equivalent | |
| K082425 | TANDEMHEART TRANSSEPTAL CANNULA- EF 72 | DWF | Substantially Equivalent | |
| K061369 | TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 | DWA | Substantially Equivalent | |
| K052570 | TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 | DWF | Substantially Equivalent | |
| K030398 | CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 | DQR | Substantially Equivalent | |
| K991783 | AB-180 XC SYSTEM, MODEL AB-180XC | KFM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use
- DQRCannula, Catheter
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- DREDilator, Vessel, For Percutaneous Catheterization
- PZSDual Lumen Ecmo Cannula
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain