The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Advanced Cardiovascular Sys Low Profile Pta Balloo.
Device ID | K851854 |
510k Number | K851854 |
Device Name: | ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
Contact | Marianna F Breshini |
Correspondent | Marianna F Breshini ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
Product Code | LIT |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-26 |
Decision Date | 1985-08-05 |