FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

WALL IV EXTENSION TUBE

K Number: K940689 · Decision Mar 22, 1994
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
1
Review Days
34

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
WALL IV EXTENSION TUBE
K Number
K940689
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Walla Medical Systems, Inc.
Date Received
February 16, 1994
Decision Date
March 22, 1994
Product Code
FPA
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FPA Set, Administration, Intravascular

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.

View all