The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Rapido Cut-away Guiding Catheter.
| Device ID | K031505 |
| 510k Number | K031505 |
| Device Name: | RAPIDO CUT-AWAY GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul, MN 55112 -5798 |
| Contact | Shah M Hilali |
| Correspondent | Shah M Hilali GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul, MN 55112 -5798 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-14 |
| Decision Date | 2003-06-25 |
| Summary: | summary |