FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
5.0 Fr Arndt Endobronchial Blocker Set
K Number: K160542
·
Decision Aug 2, 2016
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
33
Applicant Total
175
Review Days
158
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Basic Information
- Device Name
- 5.0 Fr Arndt Endobronchial Blocker Set
- K Number
- K160542
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5740
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- February 26, 2016
- Decision Date
- August 2, 2016
- Product Code
- CBI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBI), ordered by most recent decision date.
Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)
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FDA Class 2
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FDA 510(k)
FDA Class 2
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Disposable Double Lumen Endobronchial Tube
FDA 510(k)
FDA Class 2
·Anesthesiology
Disposable Endobronchial Blocker Tube
FDA 510(k)
FDA Class 2
·Anesthesiology
Chartis Precision Catheter
FDA 510(k)
FDA Class 2
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sOLVe Tube
FDA 510(k)
FDA Class 2
·Anesthesiology
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