3M Cdi Quick-Cells with Heparin Treatment
FDA 510(k) K980732 · 3M Healthcare
510(k) numberK980732
Submission
- Device name
- 3M Cdi Quick-Cells with Heparin Treatment
- Applicant
- 3M Healthcare
Tistin, CA, US - Received
- February 25, 1998
- Decision date
- May 15, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was 3M Cdi Quick-Cells with Heparin Treatment cleared by the FDA?
3M Cdi Quick-Cells with Heparin Treatment (K980732) received a 510(k) decision of Substantially Equivalent on May 15, 1998, 79 days after the submission was received.
What is the product code of K980732?
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.