Sterile Dilator
FDA 510(k) K192195 · Galt Medical Corp.
510(k) numberK192195
Submission
- Device name
- Sterile Dilator
- Applicant
- Galt Medical Corp.
Garland, TX, US - Received
- August 13, 2019
- Decision date
- September 26, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
Other 510(k)s with product code DRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
More from Xcardia Innovation , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K182660 | GaltTWSDRB · Traditional | 05/30/2019SE |
| K173287 | Elite HV RadialDYB · Traditional | 12/21/2017SESK |
| K172487 | Coaxial Dilator Set (Micro-Introducer)DRE · Traditional | 10/16/2017SESK |
| 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 Sterile Dilator cleared by the FDA?
Sterile Dilator (K192195) received a 510(k) decision of Substantially Equivalent on September 26, 2019, 44 days after the submission was received.
What is the product code of K192195?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.