510(k) K013866
- Device
- CONVOY ADVANCED DELIVERY SHEATH KIT
- Applicant
- Boston Scientific
- 510(k) number
- K013866
- Product code
- DBY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-14
- Date received
- 2001-11-21
- Regulation
- 866.5520
- Classification name
- Fab, Rhodamine, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREA L RUTH
- Address
- 2710 Orchard Pkwy. San Jose CA US 95134 95134
FDA Registration Numbers#
- 3019906
Source Documents#
Other 510(k) Records For Product Code DBY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022067 | CONVOY ADVANCED DELIVERY SHEATH | Boston Scientific | 2002-09-11 |
| K013919 | TORFLEX TRANSSEPTAL GUIDING SHEATH | Baylis Medical Co., Inc. | 2002-02-22 |
| K013304 | BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-01-02 |
| K013282 | GORE INTRODUCER SHEATH | W. L. Gore & Associates, Inc. | 2001-12-14 |
| K771144 | RHODAMINE-CONJUGATED ANTISERUM | Kent Laboratories, Inc. | 1977-07-14 |