Elite HV Radial
FDA 510(k) K173287 · Galt Medical Corp.
510(k) numberK173287
Submission
- Device name
- Elite HV Radial
- Applicant
- Galt Medical Corp.
Garland, TX, US - Received
- October 16, 2017
- Decision date
- December 21, 2017
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K192195 | Sterile DilatorDRE · Special | 09/26/2019SE |
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| K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerDYB · Traditional | 07/05/2016SE |
| K152528 | Attachable Cath Lab Hemostasis ValveDTL · Traditional | 12/02/2015SE |
| K140028 | Galt Vti Low Insertion Valve Tearaway IntroducerDYB · Traditional | 08/21/2014SE |
| K123430 | Microslider Tearaway Introducer SetDYB · Traditional | 04/12/2013SE |
| K112398 | Triv(Tm) Valved Tearaway Introducer, Tirv(Tm) Valved Tearaway Introducer with Side PortDYB · Special | 04/12/2012SE |
| K071330 | Galtstick Introducer SystemDRE · Special | 10/31/2007SE |
| K043525 | Catheter IntroducerDYB · Special | 02/09/2005SE |
Questions and answers
When was Elite HV Radial cleared by the FDA?
Elite HV Radial (K173287) received a 510(k) decision of Unknown on December 21, 2017, 66 days after the submission was received.
What is the product code of K173287?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.