The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for .018 Hi-torque Floppy Guide Wire W/ Preshaped Tip.
| Device ID | K902755 |
| 510k Number | K902755 |
| Device Name: | .018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP |
| Classification | Wire, Guide, Catheter |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Contact | Jane E Beggs |
| Correspondent | Jane E Beggs ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-22 |
| Decision Date | 1990-09-04 |