FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
K Number: K173477
·
Decision Aug 31, 2018
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
40
Applicant Total
66
Review Days
291
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Basic Information
- Device Name
- ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
- K Number
- K173477
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icu Medical, Inc.
- Date Received
- November 13, 2017
- Decision Date
- August 31, 2018
- Product Code
- ONB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | FDA class 2 | General Hospital |
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