The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Anchor Exchange Device.
| Device ID | K955175 |
| 510k Number | K955175 |
| Device Name: | ACS ANCHOR EXCHANGE DEVICE |
| Classification | Wire, Guide, Catheter |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26351 YNEZ RD. Temecula, CA 92591 -4628 |
| Contact | Joy Tan |
| Correspondent | Joy Tan ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26351 YNEZ RD. Temecula, CA 92591 -4628 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-04-05 |
| Summary: | summary |