Valved Tearaway Introducer Generation II
FDA 510(k) K124046 · Medical Components, Inc.
510(k) numberK124046
Submission
- Device name
- Valved Tearaway Introducer Generation II
- Applicant
- Medical Components, Inc.
Harleysville, PA, US - Received
- December 31, 2012
- Decision date
- June 3, 2013
- Decision
- Substantially Equivalent (SESE)
- 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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| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
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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 |
|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen CatheterMPB · Traditional | 08/12/2025SE |
| K141633 | Pro-Picc with Valve TechnologyLJS · Traditional | 09/29/2014SE |
| K132880 | Medcomp Power Injectable Safety Huber NeedleFPA · Traditional | 01/08/2014SE |
| K131687 | 6F X 60CM Triple Pro-Line CT Basic Ir SetLJS · Traditional | 08/16/2013SE |
| K130687 | 2F & 3F Vascu-Sheath Tearaway IntroducerDYB · Traditional | 08/15/2013SE |
| K130923 | 5F Dignity CT Titanium PortLJT · Traditional | 07/31/2013SE |
| K123617 | 3F Pro-PiccLJS · Traditional | 05/15/2013SE |
| K122423 | Vasu-PiccLJS · Traditional | 12/12/2012SE |
| K121848 | Split Cath III 24CM Split Cath III 24CM Split Cath III 32CM Cath III 36CM Split Cath III…MSD · Special | 09/21/2012SESK |
| K120281 | Dignity Power Injectable Titanium PortLJT · Traditional | 09/17/2012SE |
Questions and answers
When was Valved Tearaway Introducer Generation II cleared by the FDA?
Valved Tearaway Introducer Generation II (K124046) received a 510(k) decision of Substantially Equivalent on June 3, 2013, 154 days after the submission was received.
What is the product code of K124046?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.