Cdi(Tm) H/S Cuvette, Modification
FDA 510(k) K915265 · 3M Company
510(k) numberK915265
Submission
- Device name
- Cdi(Tm) H/S Cuvette, Modification
- Applicant
- 3M Company
Tustin, CA, US - Received
- November 19, 1991
- Decision date
- January 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4330
- Specialty
- Cardiovascular
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| K181923 | Quantum Workstation 12.1DRY · Special | Spectrum Medical , Ltd. | 08/17/2018SE |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No GasDRY · Traditional | Spectrum Medical , Ltd. | 03/28/2018SE |
| K163657 | Quantum WorkstationDRY · Special | Spectrum Medical , Ltd. | 01/18/2017SE |
| K133157 | Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface…DRY · Traditional | Medtronic, Inc. | 10/23/2014SE |
| K133658 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 07/25/2014SE |
| K123039 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 11/20/2012SE |
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| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
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| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
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Questions and answers
When was Cdi(Tm) H/S Cuvette, Modification cleared by the FDA?
Cdi(Tm) H/S Cuvette, Modification (K915265) received a 510(k) decision of Substantially Equivalent on January 15, 1992, 57 days after the submission was received.
What is the product code of K915265?
The FDA product code is DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4330.