The following data is part of a premarket notification filed by Cardiovascular Imaging Systems, Inc. with the FDA for Cvis Insight Imaging Catheter For Intraluminal.
Device ID | K921631 |
510k Number | K921631 |
Device Name: | CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | CARDIOVASCULAR IMAGING SYSTEMS, INC. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 |
Contact | Stan Tillman |
Correspondent | Stan Tillman CARDIOVASCULAR IMAGING SYSTEMS, INC. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-06 |
Decision Date | 1992-07-02 |