The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Tri-lobe Balloon Catheter.
| Device ID | K033670 |
| 510k Number | K033670 |
| Device Name: | GORE TRI-LOBE BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Contact | Brandon Hansen |
| Correspondent | Brandon Hansen W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2004-05-05 |
| Summary: | summary |