MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER
FDA 510(k) clearance K955839 · decided 1996-03-25
Clearance details
- K-number
- K955839
- Device name
- MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER
- Applicant
- Baxter Edwards
- Decision
- Substantially Equivalent
- Date received
- 1995-12-26
- Decision date
- 1996-03-25
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med cathete recall (Z-0647-2017) | Centurion Medical Products Corporation | 2016-12-02 |