Pleur-Evac Autotransfusion System -Tentative
FDA 510(k) K851024 · Pfizer, Inc.
510(k) numberK851024
Submission
- Device name
- Pleur-Evac Autotransfusion System -Tentative
- Applicant
- Pfizer, Inc.
Ny, NY, US - Received
- March 12, 1985
- Decision date
- May 23, 1985
- 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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Questions and answers
When was Pleur-Evac Autotransfusion System -Tentative cleared by the FDA?
Pleur-Evac Autotransfusion System -Tentative (K851024) received a 510(k) decision of Substantially Equivalent on May 23, 1985, 72 days after the submission was received.
What is the product code of K851024?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.