The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Medical Corporation Clearway Rx Catheter.
| Device ID | K061680 |
| 510k Number | K061680 |
| Device Name: | ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Joseph P Depaolo |
| Correspondent | Joseph P Depaolo ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-15 |
| Decision Date | 2006-12-15 |