The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Low Profile Steerable Balloon Dilation.
| Device ID | K843880 |
| 510k Number | K843880 |
| Device Name: | LOW PROFILE STEERABLE BALLOON DILATION |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View, CA 04043 |
| Contact | Jane E Beggs |
| Correspondent | Jane E Beggs ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View, CA 04043 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-02 |
| Decision Date | 1984-11-27 |