510(k) K870411

CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA. by Medical Surgical Concepts, Inc. — Product Code DQY

K870411 is an FDA 510(k) premarket notification submitted by Medical Surgical Concepts, Inc. for the device "CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA.". The FDA issued a decision of Substantially Equivalent on June 2, 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
June 2, 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