Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr Series)
FDA 510(k) K973475 · Medtronic Vascular
510(k) numberK973475
Submission
- Device name
- Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr Series)
- Applicant
- Medtronic Vascular
Anaheim, CA, US - Received
- September 12, 1997
- Decision date
- November 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4240
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | Sorin Group Italia S.R.L. | 05/30/2025SE |
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| K173716 | MPS2 Myocardial Protection System ConsoleDTR · Traditional | Quest Medical, Inc. | 10/01/2018SE |
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Questions and answers
When was Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr Series) cleared by the FDA?
Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr Series) (K973475) received a 510(k) decision of Substantially Equivalent on November 20, 1997, 69 days after the submission was received.
What is the product code of K973475?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.