The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cardiac Catheterization Kit.
Device ID | K932141 |
510k Number | K932141 |
Device Name: | CARDIAC CATHETERIZATION KIT |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Contact | Frederick Gustafson |
Correspondent | Frederick Gustafson ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-22 |
Decision Date | 1994-09-22 |