Pilot Tube Repair Kit
FDA 510(k) K113644 · Instrumentation Industries, Inc.
510(k) numberK113644
Submission
- Device name
- Pilot Tube Repair Kit
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- December 12, 2011
- Decision date
- January 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSK – Cuff, Tracheal Tube, Inflatable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5750
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Pilot Tube Repair Kit cleared by the FDA?
Pilot Tube Repair Kit (K113644) received a 510(k) decision of Substantially Equivalent on January 26, 2012, 45 days after the submission was received.
What is the product code of K113644?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.