TSI Transseptal Introducer
FDA 510(k) K181031 · Pressure Products Medical Device Manufacturing, LLC
510(k) numberK181031
Submission
- Device name
- TSI Transseptal Introducer
- Applicant
- Pressure Products Medical Device Manufacturing, LLC
Morton, PA, US - Received
- April 18, 2018
- Decision date
- October 26, 2018
- 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 |
| 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 |
|---|---|---|
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135…DXF · Special | 03/13/2026SE |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)DRC · Special | 05/17/2024SE |
| K221707 | SafeSept® Transseptal Guidewire (SS-140)DRC · Special | 09/14/2022SE |
| K210328 | SafeSept Blunt NeedleDRC · Special | 03/05/2021SE |
| K172950 | TSN Transseptal NeedleDRC · Traditional | 02/21/2018SE |
| K172934 | Needle Free Transseptal CannulaDRC · Traditional | 02/16/2018SE |
| K172893 | SafeSept Needle Free Transseptal GuidewireDRC · Traditional | 12/21/2017SE |
| K170671 | SafeSept Transseptal GuidewireDRC · Traditional | 10/20/2017SE |
Questions and answers
When was TSI Transseptal Introducer cleared by the FDA?
TSI Transseptal Introducer (K181031) received a 510(k) decision of Substantially Equivalent on October 26, 2018, 191 days after the submission was received.
What is the product code of K181031?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.