510(k) K854601

SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH by Concord Laboratories, Inc. — Product Code BSO

K854601 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH". The FDA issued a decision of Substantially Equivalent on January 10, 1986. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1986
Date Received
November 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type