ClearanceBrief
510(k) K981284 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass

BETTER-BLADDER (BB)

ApplicantCirculatory Technology, Inc., Oyster Bay NY, US
DecisionSubstantially Equivalent, Aug 12, 1998
ReceivedApr 8, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K981284

DateFirm and productCodeLinked 510(k)
Apr 27, 2021Circulatory Technology Inc.
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Open, Classified		 DTNNone listed
Mar 1, 2018Circulatory Technology Inc
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
Terminated		 DTNNone listed
Mar 1, 2018Circulatory Technology Inc
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
Terminated		 DTNNone listed
Oct 7, 2016Circulatory Technology Inc
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Terminated		 DTNNone listed
Jul 1, 2016Circulatory Technology Inc
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal
Terminated		 DTNNone listed
Mar 3, 2016Circulatory Technology Inc
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Terminated		 DTNNone listed
Apr 13, 2010Circulatory Technology Inc
The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-
Terminated		 DTNNone listed

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