The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Low Profile Steerable Balloon Dilata.
Device ID | K831403 |
510k Number | K831403 |
Device Name: | LOW PROFILE STEERABLE BALLOON DILATA |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LIT |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-02 |
Decision Date | 1983-06-08 |