Harvesting Tube
FDA 510(k) K892857 · Conmedcorp
510(k) numberK892857
Submission
- Device name
- Harvesting Tube
- Applicant
- Conmedcorp
Utica, NY, US - Received
- April 18, 1989
- Decision date
- June 15, 1989
- 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 Harvesting Tube cleared by the FDA?
Harvesting Tube (K892857) received a 510(k) decision of Substantially Equivalent on June 15, 1989, 58 days after the submission was received.
What is the product code of K892857?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.