Shiley Specialized,Pediatric & Neonatal Trach.Tube
FDA 510(k) K925615 · Sorin Biomedica, Fiat, USA, Inc.
510(k) numberK925615
Submission
- Device name
- Shiley Specialized,Pediatric & Neonatal Trach.Tube
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
Irvine, CA, US - Received
- November 6, 1992
- Decision date
- March 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CBI – Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5740
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Shiley Specialized,Pediatric & Neonatal Trach.Tube cleared by the FDA?
Shiley Specialized,Pediatric & Neonatal Trach.Tube (K925615) received a 510(k) decision of Substantially Equivalent on March 26, 1993, 140 days after the submission was received.
What is the product code of K925615?
The FDA product code is CBI – Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5740.