The following data is part of a premarket notification filed by Heartware Intl. Corp. with the FDA for Hearttrack Quantitative Coronary Angiography Softw.
| Device ID | K933058 |
| 510k Number | K933058 |
| Device Name: | HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW |
| Classification | System, X-ray, Angiographic |
| Applicant | HEARTWARE INTL. CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia Sinclair |
| Correspondent | Cynthia Sinclair HEARTWARE INTL. CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-22 |
| Decision Date | 1993-09-28 |