Receptal Ats Mediastinal Liner
FDA 510(k) K772280 · Sorensen Research
510(k) numberK772280
Submission
- Device name
- Receptal Ats Mediastinal Liner
- Applicant
- Sorensen Research
Mchenry, IL, US - Received
- December 9, 1977
- Decision date
- January 3, 1978
- 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 Receptal Ats Mediastinal Liner cleared by the FDA?
Receptal Ats Mediastinal Liner (K772280) received a 510(k) decision of Substantially Equivalent on January 3, 1978, 25 days after the submission was received.
What is the product code of K772280?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.