BAXTER HEMOSTASIS VALVE INTRODUCERS
FDA 510(k) clearance K981909 · decided 1998-11-24
Clearance details
- K-number
- K981909
- Device name
- BAXTER HEMOSTASIS VALVE INTRODUCERS
- Applicant
- Baxter Edwards
- Decision
- Substantially Equivalent
- Date received
- 1998-06-01
- Decision date
- 1998-11-24
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifes recall (Z-2776-2011) | Edwards Lifesciences, LLC | 2011-07-11 |
| Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifescien recall (Z-2777-2011) | Edwards Lifesciences, LLC | 2011-07-11 |
| Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. In recall (Z-1913-2009) | Edwards Lifesciences, Llc | 2009-08-25 |