The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Acuity Steerable Stylet Accessory.
| Device ID | K053019 |
| 510k Number | K053019 |
| Device Name: | ACUITY STEERABLE STYLET ACCESSORY |
| Classification | Stylet, Catheter |
| Applicant | GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul, MN 55112 -5798 |
| Contact | Jennifer X Tang |
| Correspondent | Jennifer X Tang GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul, MN 55112 -5798 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2006-03-03 |
| Summary: | summary |