Medline Stopcock and Manifold
FDA 510(k) K120069 · Medline Industries, Inc.
510(k) numberK120069
Submission
- Device name
- Medline Stopcock and Manifold
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- January 9, 2012
- Decision date
- April 3, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4290
- Specialty
- Cardiovascular
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| K113845 | Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceDTL · Special | Medtronic, Inc. | 01/25/2012SE |
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Questions and answers
When was Medline Stopcock and Manifold cleared by the FDA?
Medline Stopcock and Manifold (K120069) received a 510(k) decision of Substantially Equivalent on April 3, 2012, 85 days after the submission was received.
What is the product code of K120069?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.