510(k) K870412

TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT by Medical Surgical Concepts, Inc. — Product Code DQY

K870412 is an FDA 510(k) premarket notification submitted by Medical Surgical Concepts, Inc. for the device "TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT". The FDA issued a decision of Substantially Equivalent on May 27, 1987. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Medical Surgical Concepts, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1987
Date Received
February 3, 1987
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