The following data is part of a premarket notification filed by Heartware Intl. Corp. with the FDA for Heartview(r) Coronary Angiograph Diagram/report Sy.
| Device ID | K932410 |
| 510k Number | K932410 |
| Device Name: | HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY |
| Classification | System, X-ray, Angiographic |
| Applicant | HEARTWARE INTL. CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A 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 | 1993-05-18 |
| Decision Date | 1993-12-13 |