New Lead Introducer Kits, Various Models
FDA 510(k) K926340 · Telectronics Pacing Systems, Inc.
510(k) numberK926340
Submission
- Device name
- New Lead Introducer Kits, Various Models
- Applicant
- Telectronics Pacing Systems, Inc.
Washington, DC, US - Received
- December 17, 1992
- Decision date
- May 27, 1993
- 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
Other 510(k)s with product code DYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…DYB · Traditional | Hartman Medical Group, LLC | 07/06/2026SE |
| 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 |
|---|---|---|
| K961118 | Maxim PF Models 033-581/033-590DTB · Traditional | 07/15/1996ST |
| K943657 | SterilizationDTB · Traditional | 06/24/1996ST |
| K934899 | Bifurcated Lead Adaptors, 3.2MM & 5.0 MMDTD · Traditional | 05/12/1994SE |
| K914489 | New Extrusion Vendor for Polyurethane TubingDTB · Traditional | 08/17/1992SE |
| K913919 | Universal Terminal Cap, 3.2MMKFJ · Traditional | 12/31/1991SE |
| K912773 | Unipolar Upsizing AdaptorDTD · Traditional | 10/23/1991SE |
| K911273 | 100 CM Permanent Pacing Lead ModelsDTB · Traditional | 08/28/1991SE |
| K910112 | Bifurcated VS-1 to VS-1 Lead AdaptorDTD · Traditional | 02/25/1991SE |
| K903186 | Optima Series II Model 147B Single Chamber PulseDXY · Traditional | 01/18/1991SE |
| K904741 | Laserdish Poly Unipolar Ventri Lead W/Trail TinesDTB · Traditional | 01/08/1991SE |
Questions and answers
When was New Lead Introducer Kits, Various Models cleared by the FDA?
New Lead Introducer Kits, Various Models (K926340) received a 510(k) decision of Substantially Equivalent on May 27, 1993, 161 days after the submission was received.
What is the product code of K926340?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.