510(k) K945473

V-CATH BREAKAWAY NEEDLE INTRODUCER by Hdc Corp. — Product Code KZH

K945473 is an FDA 510(k) premarket notification submitted by Hdc Corp. for the device "V-CATH BREAKAWAY NEEDLE INTRODUCER". The FDA issued a decision of Substantially Equivalent on January 20, 1995. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Hdc Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1995
Date Received
November 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Syringe Needle
Device Class
Class II
Regulation Number
880.6920
Review Panel
HO
Submission Type