VORTRAN Cuff Inflator (VCI)
FDA 510(k) K173914 · Vortran Medical Technology 1, Inc.
510(k) numberK173914
Submission
- Device name
- VORTRAN Cuff Inflator (VCI)
- Applicant
- Vortran Medical Technology 1, Inc.
Sacramento, CA, US - Received
- December 22, 2017
- Decision date
- May 25, 2018
- 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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| K103639 | Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)-…CAP · Traditional | 09/15/2011SE |
| K073261 | Var MonitorBTL · Special | 05/23/2008SE |
| K041473 | Var-Plus (Vortran Automatic Resuscitator), Model PCMBTL · Traditional | 07/15/2004SE |
| K003684 | Percussiveneb, Model PN-2001NHJ · Special | 02/23/2001SE |
| K001430 | Respirtech PRO-O2C, Model 2200 and Respirtech Pro, Model 2000BTL · Traditional | 07/05/2000SE |
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Questions and answers
When was VORTRAN Cuff Inflator (VCI) cleared by the FDA?
VORTRAN Cuff Inflator (VCI) (K173914) received a 510(k) decision of Substantially Equivalent on May 25, 2018, 154 days after the submission was received.
What is the product code of K173914?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.