The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrac Tm Multipurpose Balloon Catheter.
Device ID | K820646 |
510k Number | K820646 |
Device Name: | ATRAC TM MULTIPURPOSE BALLOON CATHETER |
Classification | Catheter, Embolectomy |
Applicant | ATRIUM MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-09 |
Decision Date | 1982-03-25 |