SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
FDA 510(k) clearance K003731 · decided 2001-04-10
Clearance details
- K-number
- K003731
- Device name
- SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
- Applicant
- Thomas Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-04
- Decision date
- 2001-04-10
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R recall (Z-0168-2012) | Thomas Medical Products Inc | 2012-01-11 |
| Thomas Medical Products, Y-Glide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary By recall (Z-1225-2011) | Thomas Medical Products Inc | 2011-02-14 |
| Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Val recall (Z-1227-2011) | Thomas Medical Products Inc | 2011-02-14 |
| Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve recall (Z-1228-2011) | Thomas Medical Products Inc | 2011-02-14 |
| Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introdu recall (Z-0661-2010) | Thomas Medical Products Inc | 2010-02-02 |
| 18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer Sys recall (Z-0131-2009) | Thomas Medical Products Inc | 2008-11-03 |