The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Ptca Balloon Catheters & Accessories.
| Device ID | K843944 |
| 510k Number | K843944 |
| Device Name: | PTCA BALLOON CATHETERS & ACCESSORIES |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View, CA 04043 |
| Contact | Earle L Canty |
| Correspondent | Earle L Canty ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View, CA 04043 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-09 |
| Decision Date | 1985-02-14 |