Davol Orthopaedic Autotransfusion System
FDA 510(k) K914119 · Davol, Inc.
510(k) numberK914119
Submission
- Device name
- Davol Orthopaedic Autotransfusion System
- Applicant
- Davol, Inc.
Cranston, RI, US - Received
- September 13, 1991
- Decision date
- December 3, 1992
- 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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| K003790 | Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002…GCJ · Traditional | 12/22/2000SE |
| K931899 | Davol AtsCAC · Traditional | 11/15/1994SE |
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Questions and answers
When was Davol Orthopaedic Autotransfusion System cleared by the FDA?
Davol Orthopaedic Autotransfusion System (K914119) received a 510(k) decision of Substantially Equivalent on December 3, 1992, 447 days after the submission was received.
What is the product code of K914119?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.