The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Clearway Otw Model 85912.
| Device ID | K093431 |
| 510k Number | K093431 |
| Device Name: | CLEARWAY OTW MODEL 85912 |
| Classification | Catheter, Percutaneous |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Raymond Kelly |
| Correspondent | Raymond Kelly 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 | 2009-11-04 |
| Decision Date | 2010-04-20 |