The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Modification To Supercross Catheter.
Device ID | K014118 |
510k Number | K014118 |
Device Name: | MODIFICATION TO SUPERCROSS CATHETER |
Classification | Catheter, Percutaneous |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
Contact | Sevrina Ciucci |
Correspondent | Sevrina Ciucci ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-14 |
Decision Date | 2002-01-11 |
Summary: | summary |