510(k) K951384

V-CATH PERCUTANEOUS INTRODUCER KIT by Hdc Corp. — Product Code KZH

K951384 is an FDA 510(k) premarket notification submitted by Hdc Corp. for the device "V-CATH PERCUTANEOUS INTRODUCER KIT". The FDA issued a decision of Substantially Equivalent on June 23, 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
June 23, 1995
Date Received
March 27, 1995
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