The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Modification To Viking Optima Guiding Catheter.
| Device ID | K013638 |
| 510k Number | K013638 |
| Device Name: | MODIFICATION TO VIKING OPTIMA GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Contact | Nancy E Ralston |
| Correspondent | Nancy E Ralston GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2001-12-04 |
| Summary: | summary |