TightRail Mini
TightRail Mini is a rotating dilator sheath used to free tissue around cardiac leads, indwelling catheters or other objects during removal. A proximal trigger handle operates a dilation…
TightRail Mini is a rotating dilator sheath used to free tissue around cardiac leads, indwelling catheters or other objects during removal. A proximal trigger handle operates a dilation mechanism at the sheath’s distal end.
The sheath advances, withdraws and rotates around the object being removed. Rotation of an inner shaft is converted through a cam mechanism into axial movement of the distal dilation components, separating surrounding tissue and fibrous attachments.
Listed Item
TightRail Mini™ Rotating Dilator Sheath
Short Sheath Configuration
The Mini has a nominal working length of 15.5 cm and is available in 9 and 11 Fr sizes. It is packaged with an outer support sheath. Its shorter distal dilation sheath distinguishes it from the longer TightRail configuration while retaining the same mechanical operating principle.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifetech Scientific (Shenzhen) Co,.ltd | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Spectranetics Corp., United States |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K141131 |
| Record published | 2015-02-06 |
| Record revised | 2024-06-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry |
| Sizes | Lumen/inner diameter 0.119 to 0.145 in; outer diameter 0.207 to 0.234 in; length 15.5 cm |
| Distribution end date | 2019-02-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 540-011 | Lumen/Inner Diameter 0.145 in | In distribution |
| 540-011AA | Lumen/Inner Diameter 0.145 in | In distribution |
| 540-009 | Lumen/Inner Diameter 0.119 in | In distribution |
| 540-009AA | Lumen/Inner Diameter 0.119 in | In distribution |
| 540-011 | Lumen/Inner Diameter 0.145 in | Withdrawn |
| 540-009 | Lumen/Inner Diameter 0.119 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prelude® | Merit Medical Systems, Inc. | 323 |
| Prelude PRO™ | Merit Medical Systems, Inc. | 132 |
| Cook | Cook Incorporated | 125 |
| Avanti | Cordis Corp. | 81 |
| Dilator, Vessel, For Percutaneous Catheterization | B. Braun Interventional Systems, Inc. | 59 |
| Merit MAK™ | Merit Medical Systems, Inc. | 49 |
| Prelude ACT™ | Merit Medical Systems, Inc. | 38 |
| AngioDynamics | Navilyst Medical, Inc. | 38 |
| Super Sheath | Togo Medikit Co., Ltd. | 31 |
| Avanti | Cordis US Corp. | 29 |
| Mini Stick MAX | AngioDynamics, Inc. | 28 |
| OneStic Micro-Access Introducer | Argon Medical Devices, Inc. | 27 |
Showing 12 of 159. All products under Dilator, Vessel, For Percutaneous Catheterization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223472 | 2022-12-15 |
| K212784 | 2022-08-24 |
| K161333 | 2016-07-08 |
| K150360 | 2015-03-04 |
| K142546 | 2014-09-25 |
| K141131 | 2014-05-23 |
| K140047 | 2014-04-09 |
| K133631 | 2014-03-27 |
| K092378 | 2009-11-02 |
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.