K022067 is an FDA 510(k) clearance for the CONVOY ADVANCED DELIVERY SHEATH. This device is classified as a Fab, Rhodamine, Antigen, Antiserum, Control (Class I - General Controls, product code DBY).
Submitted by Boston Scientific (San Jose, US). The FDA issued a Cleared decision on September 11, 2002, 78 days after receiving the submission on June 25, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5520.
| 510(k) Number | K022067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2002 |
| Decision Date | September 11, 2002 |
| Days to Decision | 78 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 |