PathBuilder Transseptal Needle
PathBuilder Transseptal Needle is used to puncture the wall between the heart's atria during catheterization, providing access to the left side of the heart. It is used with a catheter…
PathBuilder Transseptal Needle is used to puncture the wall between the heart’s atria during catheterization, providing access to the left side of the heart. It is used with a catheter introducer and dilator.
The needle has a curved distal section and a beveled tip. Its diameter steps down within the curve to fit the dilator, while a pointer flange at the proximal end indicates the direction of the curve.
Needle and Stylet
A proximal hub permits aspiration or fluid injection. The straight stylet helps the needle enter the dilator, and its curved proximal end locks onto the hub when inserted. The needle, hub, orientation flange and stylet form the working assembly used to position the tip for the septal puncture.
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (2), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Changzhou 3R Medical Device Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 16 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Changzhou Lookmed Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
Record
| Listed by | Shanghai Microport EP Medtech Co., Ltd., China |
|---|---|
| FDA product code | DRC |
| Device type | Trocar |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1390 |
| Establishment | Manufacturer |
| 510(k) | K212625 |
| Record published | 2024-02-22 |
| Record revised | 2026-05-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TNL7118 | In distribution | |
| TNL8918 | In distribution | |
| TNL9818 | In distribution | |
| TNM8918 | In distribution | |
| TNM7118 | In distribution | |
| TNM5619 | In distribution | |
| TNM9818 | In distribution | |
| TNS5619 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 107 |
| Trocar | Doppkon Gmbh & Co. KG | 53 |
| Merit Advance® | Merit Medical Systems, Inc. | 39 |
| HeartSpan® | Merit Medical | 29 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 22 |
| Argyle | Cardinal Health | 20 |
| Apple-Hunt Secondary Cannula | Coopersurgical, Inc. | 20 |
| HeartSpan® | Merit Medical Systems, Inc. | 16 |
| AngioDynamics | AngioDynamics, Inc. | 16 |
| Majestik® | Merit Medical Systems, Inc. | 14 |
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Argyle | Cardinal Health 200, LLC | 8 |
Showing 12 of 57. All products under Trocar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212625 | 2022-03-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.