← FDA Medical Device Classifications

One-Way Air-Leak Valve

OAZ · f · Unknown

Classification

FDA Product Code
OAZ
Device class
f
Regulation
Review panel
AN
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Definition

To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.

Market data

Cleared 510(k) submissions
0
Registered establishments
3

Source

Authoritative
FDA Device Classification database
Machine
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