510(k) K202751
- Device
- TandemHeart Pump And Escort Controller
- Applicant
- CardiacAssist, Inc.
- 510(k) number
- K202751
- Product code
- QNR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-26
- Date received
- 2020-09-21
- Regulation
- 510(k) Premarket Notification
- Classification name
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Megan Walsh
- Address
- 620 Alpha Dr. Suite 2 Pittsburg PA US 15238 15238
FDA Registration Numbers#
- 3010163695
- 3003306248
- 2133810
- 3004593495
- 9617601
- 2916596
- 3011468686
- 9611665
- 1218444
Source Documents#
Other 510(k) Records For Product Code QNR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250199 | VitalFlow Console | Medtronic, Inc. | 2025-05-20 |
| K234118 | CentriMag™ Acute Circulatory Support System | ABBOTT MEDICAL | 2024-01-26 |
| K233736 | LifeSPARC System | Cardiacassist, Inc. | 2024-01-19 |
| K223898 | VitalFlowTM Centrifugal Pump | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| K230364 | VitalFlow™ Console | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| K222038 | CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System | Abbott (Formerly Thoratec Corporation) | 2022-12-08 |
| K211830 | LifeSPARC System | Cardiacassist, Inc. | 2022-11-15 |
Legacy Summary#
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FDA Review#
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