The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Guidant Balloon Catheter, Several Models.
| Device ID | K021283 |
| 510k Number | K021283 |
| Device Name: | GUIDANT BALLOON CATHETER, SEVERAL MODELS |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-18 |
| Decision Date | 2002-05-02 |
| Summary: | summary |