510(k) K852491

AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER by American Pharmaseal Div. Ahsc — Product Code DQY

K852491 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent on September 25, 1985. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1985
Date Received
June 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type