The following data is part of a premarket notification filed by Guidant Corporation, Cardiac Surgery with the FDA for Vasoview 5 Harvesting Cannula.
Device ID | K020143 |
510k Number | K020143 |
Device Name: | VASOVIEW 5 HARVESTING CANNULA |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | GUIDANT CORPORATION, CARDIAC SURGERY 3200 LAKESIDE DR. Santa Clara, CA 95054 |
Contact | Anne Schlagenhaft |
Correspondent | Peter N Ruys N.V. KEMA P.O. BOX 9035 6800 ET ARNHEM Arnhem, NL |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2002-01-16 |
Decision Date | 2002-02-20 |
Summary: | summary |