The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Medical Corporation Clearway Ptfe Balloon Catheter.
| Device ID | K002627 |
| 510k Number | K002627 |
| Device Name: | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Rebecca Dolloff |
| Correspondent | Rebecca Dolloff ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-23 |
| Decision Date | 2001-04-26 |