The following data is part of a premarket notification filed by Leocor, Inc. with the FDA for Leocor Guiding Catheter.
| Device ID | K911270 |
| 510k Number | K911270 |
| Device Name: | LEOCOR GUIDING CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | LEOCOR, INC. 1301 REGENTS PK. DR. Houston, TX 77058 |
| Contact | Roger W Snyder |
| Correspondent | Roger W Snyder LEOCOR, INC. 1301 REGENTS PK. DR. Houston, TX 77058 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-22 |
| Decision Date | 1992-01-17 |