510(k) K020143

VASOVIEW 5 HARVESTING CANNULA by Guidant Corporation, Cardiac Surgery — Product Code HET

K020143 is an FDA 510(k) premarket notification submitted by Guidant Corporation, Cardiac Surgery for the device "VASOVIEW 5 HARVESTING CANNULA". The FDA issued a decision of Substantially Equivalent on February 20, 2002. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Guidant Corporation, Cardiac Surgery has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2002
Date Received
January 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type