Cdi(Tm) 300, 400 & 100, Modification
FDA 510(k) K915255 · 3M Company
510(k) numberK915255
Submission
- Device name
- Cdi(Tm) 300, 400 & 100, Modification
- Applicant
- 3M Company
Tustin, CA, US - Received
- November 18, 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
Other 510(k)s with product code DRY
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|---|---|---|---|
| K234065 | CDI OneView Monitoring SystemDRY · Traditional | Terumo Cardiovascular Systems Corporation | 04/25/2024SE |
| K202154 | B-CaptaDRY · Traditional | Livanova Deutschland, GmbH | 04/01/2021SE |
| K202557 | Quantum Workstation 12 EliteDRY · Special | Spectrum Medical , Ltd. | 10/02/2020SE |
| K182110 | CDI Blood Parameter Monitoring System 550DRY · Traditional | Terumo Cardiovascular Systems Corporation | 11/02/2018SE |
| 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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| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was Cdi(Tm) 300, 400 & 100, Modification cleared by the FDA?
Cdi(Tm) 300, 400 & 100, Modification (K915255) received a 510(k) decision of Substantially Equivalent on January 15, 1992, 58 days after the submission was received.
What is the product code of K915255?
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.