510(k) K200263

Health Line CT Midline Catheter by Health Line International Corporation — Product Code FOZ

K200263 is an FDA 510(k) premarket notification submitted by Health Line International Corporation for the device "Health Line CT Midline Catheter". The FDA issued a decision of Substantially Equivalent on March 12, 2020. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Health Line International Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2020
Date Received
February 3, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type