The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Ct Transcatheter Aortic Valve Implantation (tavi) Planning Application.
Device ID | K132524 |
510k Number | K132524 |
Device Name: | CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION |
Classification | System, X-ray, Tomography, Computed |
Applicant | PHILIPS MEDICAL SYSTEMS 595 MINER ROAD Cleveland, OH 44143 |
Contact | Susan Quick |
Correspondent | Susan Quick PHILIPS MEDICAL SYSTEMS 595 MINER ROAD Cleveland, OH 44143 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-12 |
Decision Date | 2014-06-13 |
Summary: | summary |