Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh
FDA 510(k) K141432 · Maquet Cardiopulmonary, AG
510(k) numberK141432
Submission
- Device name
- Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh
- Applicant
- Maquet Cardiopulmonary, AG
Rastatt De-Bw, DE - Received
- May 30, 2014
- Decision date
- July 7, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTN – Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
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| K241053 | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous…DTN · Special | Medtronic Cardiac Surgery | 05/15/2024SE |
| K223361 | BMR 1900 PhisioDTN · Traditional | Sorin Group Italia S.R.L. | 06/10/2023SE |
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| K153143 | Capiox Advance Hardshell ReservoirDTN · Special | Terumo Cardiovascular Systems Corporation | 12/02/2015SE |
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| K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceDTN · Special | Medtronic, Inc. | 06/12/2014SE |
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| K132829 | Quadrox-I, Quadrox-Id, Quadrox-Ir OxygenatorsDTZ · Special | 10/08/2013SE |
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Questions and answers
When was Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh cleared by the FDA?
Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh (K141432) received a 510(k) decision of Substantially Equivalent on July 7, 2014, 38 days after the submission was received.
What is the product code of K141432?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.