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510(k) K162165 · MEA Pump, Infusion, Pca

ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

Applicant	Summit Medical Products, Inc., Sandy UT, US
Decision	Substantially Equivalent, Aug 29, 2017
Received	Aug 3, 2016
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K162165

Date	Firm and product	Code	Linked 510(k)
Jun 6, 2023	Avanos Medical, Inc. AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 Terminated	FRN	None listed
Jun 6, 2023	Avanos Medical, Inc. AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 Terminated	FRN	None listed
Jun 6, 2023	Avanos Medical, Inc. SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 Terminated	FRN	None listed
Jun 6, 2023	Avanos Medical, Inc. SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 Terminated	FRN	None listed
Jun 6, 2023	Avanos Medical, Inc. ambIT Cassette Filter Male Luer, Product Code: 220266 Terminated	FRN	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.