TightRail™
TightRail™ Rotating Dilator Sheath
1manufacturer
6catalogue numbers in this listing
9510(k) clearances naming this product code
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 |
| Record published | 2015-03-12 |
| Record revised | 2021-10-26 (version 4) |
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 | Storage environment temperature up to 140 °F; Special storage condition: Keep Dry |
| Sizes | Lumen/inner diameter 0.119 to 0.171 in |
| Distribution end date | 2019-02-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 545-513AA | Lumen/Inner Diameter 0.171 in | In distribution |
| 545-509AA | Lumen/Inner Diameter 0.119 in | In distribution |
| 545-511AA | Lumen/Inner Diameter 0.145 in | In distribution |
| 545-509 | Lumen/Inner Diameter 0.119 in | Withdrawn |
| 545-511 | Lumen/Inner Diameter 0.145 in | Withdrawn |
| 545-513 | Lumen/Inner Diameter 0.171 in | Withdrawn |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.