510(k) K841530

DOUBLE LUMEN SUBLCAVIAN-FEMORAL by Medical Components, Inc. — Product Code KNZ

K841530 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "DOUBLE LUMEN SUBLCAVIAN-FEMORAL". The FDA issued a decision of Substantially Equivalent on June 25, 1984. The device falls under product code KNZ (Accessories, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Medical Components, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1984
Date Received
April 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, A-V Shunt
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type