The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Balloon Sheath.
| Device ID | K070770 |
| 510k Number | K070770 |
| Device Name: | GORE BALLOON SHEATH |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | W. L. GORE & ASSOCIATES, INC. 2647 LIN GATE COURT Pleasanton, CA 94566 |
| Contact | Alan Curtis |
| Correspondent | Alan Curtis W. L. GORE & ASSOCIATES, INC. 2647 LIN GATE COURT Pleasanton, CA 94566 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-20 |
| Decision Date | 2007-06-29 |
| Summary: | summary |