The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Rapido Cut-away Cutter.
| Device ID | K031459 |
| 510k Number | K031459 |
| Device Name: | RAPIDO CUT-AWAY CUTTER |
| Classification | Catheter, Percutaneous |
| Applicant | GUIDANT CORP. 4100 Hamline Avenue North St. Paul, MN 55112 -5798 |
| Contact | Shah Hilali |
| Correspondent | Shah Hilali GUIDANT CORP. 4100 Hamline Avenue North St. Paul, MN 55112 -5798 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-08 |
| Decision Date | 2003-07-23 |
| Summary: | summary |