The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Dryseal Sheath.
| Device ID | K120428 |
| 510k Number | K120428 |
| Device Name: | GORE DRYSEAL SHEATH |
| Classification | Introducer, Catheter |
| Applicant | W. L. GORE & ASSOCIATES, INC. 1505 N. FOURTH ST. Flagstaff, AZ 86004 |
| Contact | Nancy B Lowe |
| Correspondent | Nancy B Lowe W. L. GORE & ASSOCIATES, INC. 1505 N. FOURTH ST. Flagstaff, AZ 86004 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-13 |
| Decision Date | 2012-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132612185 | K120428 | 000 |
| 00733132612178 | K120428 | 000 |
| 00733132612161 | K120428 | 000 |
| 00733132612154 | K120428 | 000 |
| H373SDV18283 | K120428 | 000 |
| 00733132612123 | K120428 | 000 |
| 00733132612116 | K120428 | 000 |