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 |