The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Finishing Wire Supportrak.
Device ID | K041762 |
510k Number | K041762 |
Device Name: | FINISHING WIRE SUPPORTRAK |
Classification | Wire, Guide, Catheter |
Applicant | GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul, MN 55112 -5498 |
Contact | Jennifer Tang |
Correspondent | Jennifer Tang GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul, MN 55112 -5498 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-06-30 |
Decision Date | 2004-08-06 |
Summary: | summary |