K013282 is an FDA 510(k) clearance for the GORE INTRODUCER SHEATH. This device is classified as a Fab, Rhodamine, Antigen, Antiserum, Control (Class I - General Controls, product code DBY).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on December 14, 2001, 73 days after receiving the submission on October 2, 2001.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5520.
| 510(k) Number | K013282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2001 |
| Decision Date | December 14, 2001 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DBY — Fab, Rhodamine, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5520 |