Circulatory Technology, Inc.
Circulatory Technology, Inc. holds FDA 510(k) medical device clearances, first cleared 1994, most recent 2014, with 6 FDA device recalls on record.
Top product codes for Circulatory Technology, Inc.
FDA recalls by Circulatory Technology, Inc.
- Z-1862-2021 — The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
- Z-0817-2018 — Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
- Z-1171-2018 — **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)
- Z-0057-2017 — 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.
- Z-2832-2016 — 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 circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
- Z-2050-2016 — Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Circulatory Technology, Inc.
- K140321 — INITARY BETTER BLADDER-PEDIATRIC
- K012942 — THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
- K001822 — THE V-BAG
- K981284 — BETTER-BLADDER (BB)
- K964205 — BETTER-TUBING
- K964337 — BETTER-BLADDER (BB)
- K961594 — BETTER-VENTER
- K941492 — PRESSURE RELIEF VALVE
- K942933 — PRESSURE INFUSION CUFF
Data sourced from openFDA. This site is unofficial and independent of the FDA.