Cuff Pilot, Sure Seal
FDA 510(k) K142103 · Teleflexmedical, Inc.
510(k) numberK142103
Submission
- Device name
- Cuff Pilot, Sure Seal
- Applicant
- Teleflexmedical, Inc.
Morrisville, NC, US - Received
- August 1, 2014
- Decision date
- May 8, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Cuff Pilot, Sure Seal cleared by the FDA?
Cuff Pilot, Sure Seal (K142103) received a 510(k) decision of Substantially Equivalent on May 8, 2015, 280 days after the submission was received.
What is the product code of K142103?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.