Data Master Perfusion Monitoring System
FDA 510(k) K001388 · Dideco
510(k) numberK001388
Submission
- Device name
- Data Master Perfusion Monitoring System
- Applicant
- Dideco
North Attleboro, MA, US - Received
- May 2, 2000
- Decision date
- July 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary 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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| 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 |
More from Terumo Cardiovascular Systems Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K004001 | Monolyth Mimesys Hollow Fiber OxygenatorDTZ · Abbreviated | 10/04/2001SE |
| K010478 | Dideco D901 Lilliput Hollow Fiber Oxygenator with or Without Soft Venous Reservoir Bag…DTZ · Abbreviated | 09/27/2001SE |
| K936220 | Dideco Vacuum PumpCAC · Traditional | 01/27/1995SE |
| K940519 | Dideco Compact-A Autotransfusion SystemCAC · Traditional | 01/19/1995SE |
Questions and answers
When was Data Master Perfusion Monitoring System cleared by the FDA?
Data Master Perfusion Monitoring System (K001388) received a 510(k) decision of Substantially Equivalent on July 28, 2000, 87 days after the submission was received.
What is the product code of K001388?
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.