5.0 Fr Arndt Endobronchial Blocker Set
FDA 510(k) K160542 · Cook Incorporated
510(k) numberK160542
Submission
- Device name
- 5.0 Fr Arndt Endobronchial Blocker Set
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- February 26, 2016
- Decision date
- August 2, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBI – Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5740
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was 5.0 Fr Arndt Endobronchial Blocker Set cleared by the FDA?
5.0 Fr Arndt Endobronchial Blocker Set (K160542) received a 510(k) decision of Substantially Equivalent on August 2, 2016, 158 days after the submission was received.
What is the product code of K160542?
The FDA product code is CBI – Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5740.