BETTER-BLADDER (BB)— 510(k) K981284
Substantially EquivalentCirculatory Technology, Inc.
FDA 510(k) clearance K981284 for BETTER-BLADDER (BB), Substantially Equivalent on 1998-08-12. Applicant: Circulatory Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Circulatory Technology, Inc.
- Product code
- Code DTN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4400
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oyster Bay, NY, US
Recent devices under product code DTN
view allMore clearances from Circulatory Technology, Inc.
view allAdverse events under product code DTN
product code DTN- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K981284
K-number listed on FDA's recall record- 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981284.
Data sourced from openFDA. This site is unofficial and independent of the FDA.