The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Agiltrac .035 Peripheral Dilatation Catheter.
| Device ID | K022738 |
| 510k Number | K022738 |
| Device Name: | AGILTRAC .035 PERIPHERAL DILATATION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | GUIDANT CORP. 1525 O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Nadine Sakakini |
| Correspondent | Nadine Sakakini GUIDANT CORP. 1525 O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-19 |
| Decision Date | 2002-09-13 |
| Summary: | summary |