FDA Product Code
FDA Product Code DBY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5520
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022067 | CONVOY ADVANCED DELIVERY SHEATH | Boston Scientific | 2002-09-11 | Traditional | PDF ↗ |
| K013919 | TORFLEX TRANSSEPTAL GUIDING SHEATH | Baylis Medical Co., Inc. | 2002-02-22 | Traditional | PDF ↗ |
| K013304 | BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-01-02 | Traditional | PDF ↗ |
| K013282 | GORE INTRODUCER SHEATH | W. L. Gore & Associates, Inc. | 2001-12-14 | Traditional | PDF ↗ |
| K013866 | CONVOY ADVANCED DELIVERY SHEATH KIT | Boston Scientific | 2001-12-14 | Special | PDF ↗ |
| K771144 | RHODAMINE-CONJUGATED ANTISERUM | Kent Laboratories, Inc. | 1977-07-14 | Traditional | PDF ↗ |
Product code DBY · Class I · Immunology. Data: openFDA.