The following data is part of a premarket notification filed by Cardiacassist, Inc. with the FDA for Tandemheart Pump And Escort Controller.
| Device ID | K202751 |
| 510k Number | K202751 |
| Device Name: | TandemHeart Pump And Escort Controller |
| Classification | 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 |
| Applicant | CardiacAssist, Inc. 620 Alpha Drive, Suite 2 Pittsburgh, PA 15238 |
| Contact | Megan Walsh |
| Correspondent | Megan Walsh CardiacAssist, Inc. 620 Alpha Drive, Suite 2 Pittsburgh, PA 15238 |
| Product Code | QNR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-21 |
| Decision Date | 2021-03-26 |