CONVOY ADVANCED DELIVERY SHEATH
FDA 510(k) clearance K022067 · decided 2002-09-11
Clearance details
- K-number
- K022067
- Device name
- CONVOY ADVANCED DELIVERY SHEATH
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2002-06-25
- Decision date
- 2002-09-11
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- DBY
- Device class
- 1
- Regulation number
- 866.5520
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TORFLEX TRANSSEPTAL GUIDING SHEATH (K013919) | Baylis Medical Co., Inc. | 2002-02-22 |
| BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER (K013304) | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-01-02 |
| GORE INTRODUCER SHEATH (K013282) | W. L. Gore & Associates, Inc. | 2001-12-14 |
| CONVOY ADVANCED DELIVERY SHEATH KIT (K013866) | Boston Scientific | 2001-12-14 |
| RHODAMINE-CONJUGATED ANTISERUM (K771144) | Kent Laboratories, Inc. | 1977-07-14 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, recall (Z-1072-2009) | Boston Scientific Corp | 2009-04-09 |