The following data is part of a premarket notification filed by National Catheter Co. Div. Mallinckrodt with the FDA for Anthron Catheter Set.
Device ID | K802918 |
510k Number | K802918 |
Device Name: | ANTHRON CATHETER SET |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | NATIONAL CATHETER CO. DIV. MALLINCKRODT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-19 |
Decision Date | 1981-04-21 |