TORFLEX TRANSSEPTAL GUIDING SHEATH
FDA 510(k) clearance K013919 · decided 2002-02-22
Clearance details
- K-number
- K013919
- Device name
- TORFLEX TRANSSEPTAL GUIDING SHEATH
- Applicant
- Baylis Medical Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-27
- Decision date
- 2002-02-22
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DBY
- Device class
- 1
- Regulation number
- 866.5520
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mississauga, Ontario, CA
- 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 |
|---|---|---|
| CONVOY ADVANCED DELIVERY SHEATH (K022067) | Boston Scientific | 2002-09-11 |
| 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 |
|---|---|---|
| Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway recall (Z-0816-2010) | Baylis Medical Corp * | 2010-03-10 |