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Insightra Medical Inc. manufactured the Ultra Intra Aortic Balloon Pump (IABP) Catheter Kits and Double Pump devices without required FDA premarket approval (PMA) or investigational device exemption (IDE), rendering the products adulterated under federal law. The company also misbranded the IABP Catheter Kits by introducing major modifications to the device's intended use into interstate commerce without submitting a required premarket notification (510(k)), despite the device having been previously cleared under K082746. These violations were identified during an FDA inspection conducted January 21-27, 2025, at the firm's Clarksville, Tennessee facility.