The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Rapido Guiding Catheter, 6f Model# 6776; Rapido Guiding Catheter, 8f Model# 6775, 6777, 6778, 6779, 6780, 6781, 6782,.
| Device ID | K021455 |
| 510k Number | K021455 |
| Device Name: | RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, |
| Classification | Catheter, Percutaneous |
| Applicant | GUIDANT CORP. 4100 HAMLINE AVE., NORTH St. Paul, MN 55112 -5798 |
| Contact | Karen S Alsop |
| Correspondent | Karen S Alsop GUIDANT CORP. 4100 HAMLINE AVE., 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 | 2002-05-06 |
| Decision Date | 2002-08-02 |
| Summary: | summary |