Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst
FDA 510(k) K911656 · Pfizer Hospital Products Group, Inc.
510(k) numberK911656
Submission
- Device name
- Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst
- Applicant
- Pfizer Hospital Products Group, Inc.
Fall River, MA, US - Received
- April 12, 1991
- Decision date
- August 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | Sorin Group Italia S.R.L. | 04/29/2024SE |
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| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | Haemonetics Corporation | 11/15/2022SE |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | Atrium Medical Corporation | 09/03/2021SE |
| K210862 | Hemafuse SystemCAC · Traditional | Sisu Global Health | 07/29/2021SE |
| K210176 | FlowSaver Blood FilterCAC · Traditional | Inari Medical | 07/22/2021SE |
| 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 Contin. Reinfus. & Autoinfus. Syst cleared by the FDA?
Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst (K911656) received a 510(k) decision of Substantially Equivalent on August 13, 1991, 123 days after the submission was received.
What is the product code of K911656?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.