The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Clearway Rx Nb Catheter.
| Device ID | K113112 |
| 510k Number | K113112 |
| Device Name: | CLEARWAY RX NB CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Megan Mccagh |
| Correspondent | Megan Mccagh ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-20 |
| Decision Date | 2011-11-17 |