EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
FDA 510(k) clearance K043446 · decided 2005-02-04
Clearance details
- K-number
- K043446
- Device name
- EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
- Applicant
- Emmebi Srl
- Decision
- Substantially Equivalent
- Date received
- 2004-12-14
- Decision date
- 2005-02-04
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Grand Rapids, MI, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.