The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Selective Infusion Ii Catheter.
Device ID | K914751 |
510k Number | K914751 |
Device Name: | SELECTIVE INFUSION II CATHETER |
Classification | Catheter, Continuous Flush |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
Contact | Jane E Beggs |
Correspondent | Jane E Beggs ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-22 |
Decision Date | 1993-05-24 |