Auto-Vac (TM) Autotransfusion Reserv, Model 7900
FDA 510(k) K862684 · Boehringer Laboratories
510(k) numberK862684
Submission
- Device name
- Auto-Vac (TM) Autotransfusion Reserv, Model 7900
- Applicant
- Boehringer Laboratories
Norristown, PA, US - Received
- July 15, 1986
- Decision date
- October 17, 1986
- 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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| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | Fresenius Kabi AG | 02/11/2021SE |
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Questions and answers
When was Auto-Vac (TM) Autotransfusion Reserv, Model 7900 cleared by the FDA?
Auto-Vac (TM) Autotransfusion Reserv, Model 7900 (K862684) received a 510(k) decision of Substantially Equivalent on October 17, 1986, 94 days after the submission was received.
What is the product code of K862684?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.