510(k) K802580

SUBCLAVIAN CATHETER INSERTION TRAY by American Pharmaseal Div. Ahsc — Product Code KXF

K802580 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "SUBCLAVIAN CATHETER INSERTION TRAY". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code KXF (Applicator, Absorbent Tipped, Non-Sterile), a Class I device regulated under 21 CFR 880.6025. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Absorbent Tipped, Non-Sterile
Device Class
Class I
Regulation Number
880.6025
Review Panel
HO
Submission Type