S3 Cardioplegia Control Module Version 2.0
FDA 510(k) K002116 · Medical Device Consultants, Inc.
510(k) numberK002116
Submission
- Device name
- S3 Cardioplegia Control Module Version 2.0
- Applicant
- Medical Device Consultants, Inc.
North Attleboro, MA, US - Received
- July 13, 2000
- Decision date
- August 9, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4220
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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Questions and answers
When was S3 Cardioplegia Control Module Version 2.0 cleared by the FDA?
S3 Cardioplegia Control Module Version 2.0 (K002116) received a 510(k) decision of Substantially Equivalent on August 9, 2000, 27 days after the submission was received.
What is the product code of K002116?
The FDA product code is DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4220.