Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit and Optional Argyle Aqua-Seal Evacuating Autotransfusio
FDA 510(k) K970857 · Davis & Geck, Inc.
510(k) numberK970857
Submission
- Device name
- Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit and Optional Argyle Aqua-Seal Evacuating Autotransfusio
- Applicant
- Davis & Geck, Inc.
St. Louis, MO, US - Received
- March 10, 1997
- Decision date
- November 5, 1997
- 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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Questions and answers
When was Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit and Optional Argyle Aqua-Seal Evacuating Autotransfusio cleared by the FDA?
Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit and Optional Argyle Aqua-Seal Evacuating Autotransfusio (K970857) received a 510(k) decision of Substantially Equivalent on November 5, 1997, 240 days after the submission was received.
What is the product code of K970857?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.