The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atriums Pdr Thoracic Catheter.
| Device ID | K912645 |
| 510k Number | K912645 |
| Device Name: | ATRIUMS PDR THORACIC CATHETER |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis, NH 03049 |
| Contact | Ted Karwoski |
| Correspondent | Ted Karwoski ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis, NH 03049 |
| Product Code | GBS |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-17 |
| Decision Date | 1991-09-13 |