Triv(Tm) Valved Tearaway Introducer, Tirv(Tm) Valved Tearaway Introducer with Side Port
FDA 510(k) K112398 · Galt Medical
510(k) numberK112398
Submission
- Device name
- Triv(Tm) Valved Tearaway Introducer, Tirv(Tm) Valved Tearaway Introducer with Side Port
- Applicant
- Galt Medical
Buford, GA, US - Received
- August 19, 2011
- Decision date
- April 12, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K192195 | Sterile DilatorDRE · Special | 09/26/2019SE |
| 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 |
| K071330 | Galtstick Introducer SystemDRE · Special | 10/31/2007SE |
| K043525 | Catheter IntroducerDYB · Special | 02/09/2005SE |
Questions and answers
When was Triv(Tm) Valved Tearaway Introducer, Tirv(Tm) Valved Tearaway Introducer with Side Port cleared by the FDA?
Triv(Tm) Valved Tearaway Introducer, Tirv(Tm) Valved Tearaway Introducer with Side Port (K112398) received a 510(k) decision of Substantially Equivalent on April 12, 2012, 237 days after the submission was received.
What is the product code of K112398?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.