Pleur-Evac Plus Continuous Reinfusion and Autotransfusion System
FDA 510(k) K140197 · Teleflexmedical, Inc.
510(k) numberK140197
Submission
- Device name
- Pleur-Evac Plus Continuous Reinfusion and Autotransfusion System
- Applicant
- Teleflexmedical, Inc.
Research Triangle Park, NC, US - Received
- January 27, 2014
- Decision date
- October 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAC – Apparatus, Autotransfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5830
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K210862 | Hemafuse SystemCAC · Traditional | Sisu Global Health | 07/29/2021SE |
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| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | Fresenius Kabi AG | 02/11/2021SE |
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Questions and answers
When was Pleur-Evac Plus Continuous Reinfusion and Autotransfusion System cleared by the FDA?
Pleur-Evac Plus Continuous Reinfusion and Autotransfusion System (K140197) received a 510(k) decision of Substantially Equivalent on October 21, 2014, 267 days after the submission was received.
What is the product code of K140197?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.