The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Advanced Cardiovascular Systems Double Lumen Ballo.
| Device ID | K853746 |
| 510k Number | K853746 |
| Device Name: | ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Jane E Beggs |
| Correspondent | Jane E Beggs 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 | 1985-09-09 |
| Decision Date | 1985-10-21 |