510(k) K834473

MULTI-LUMEN CENTRAL VENOUS CATH. KIT by Burron Medical Products, Inc. — Product Code LJS

K834473 is an FDA 510(k) premarket notification submitted by Burron Medical Products, Inc. for the device "MULTI-LUMEN CENTRAL VENOUS CATH. KIT". The FDA issued a decision of Substantially Equivalent on April 30, 1984. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Burron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1984
Date Received
December 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type