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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device chest drainage kit
Regulation Description Vacuum-powered body fluid suction apparatus.
Definition This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodePAD
Regulation Number 880.6740
Device Class 2

Device Problems
Occlusion Within Device 2
Suction Problem 2
Use of Device Problem 1
Improper or Incorrect Procedure or Method 1
Decrease in Suction 1
Device Damaged Prior to Use 1
Stylet 1
Defective Device 1
Total Device Problems 10

Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Jan-24-2017
2 Atrium Medical Corporation II Jun-29-2015