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

VASOVIEW 5 HARVESTING CANNULA

K Number: K020143 · Decision Feb 20, 2002
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
8
Review Days
35

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
VASOVIEW 5 HARVESTING CANNULA
K Number
K020143
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
884.1720
Medical Specialty
Obstetrics/Gynecology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Guidant Corporation, Cardiac Surgery
Date Received
January 16, 2002
Decision Date
February 20, 2002
Product Code
HET
Advisory Committee
Obstetrics/Gynecology
Review Advisory Committee
OB
Third Party
Y

Classifications

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

Product Code Device Name
HET Laparoscope, Gynecologic (And Accessories)

Similar 510(k) Clearances

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

View all

Other Clearances by Guidant Corporation, Cardiac Surgery

K Number Device Name
K080169 HEARTSTRING III PROXIMAL SEAL SYSTEM
K041340 GUIDANT MICROWAVE ABLATION SYSTEM
K023630 ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
K024071 GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K023629 ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
K022718 VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
K020701 SYNCRUS INTERNAL CARDIOVERSION SYSTEM