MicroTaper™ Safety Introducer Set
The MicroTaper Safety Introducer Set places a guidewire through the skin into a peripheral blood vessel. It combines an echogenic tapered access needle with an angled nitinol guidewire. The…
The MicroTaper Safety Introducer Set places a guidewire through the skin into a peripheral blood vessel. It combines an echogenic tapered access needle with an angled nitinol guidewire. The needle incorporates a blunting mechanism intended to reduce accidental needlestick injury.
After the small-diameter wire segment enters the vessel, twisting the hub activates the needle expansion and blunting mechanism. An audible indication confirms activation and locking. The larger wire segment can then advance through the needle, which is withdrawn while the guidewire remains in place.
Set Configuration
The guidewire tapers from 0.018 to 0.035 inch and is 60 cm long. Needle lengths include 3, 4, 7, 10 and 15 cm. The set is supplied sterile for single use.
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 | Summit Access, LLC, United States |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| 510(k) | K151076 |
| Record published | 2016-09-09 |
| Record revised | 2024-10-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| Distribution end date | 2024-10-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA-04-G060 | Withdrawn | |
| SA-03-G060 | Withdrawn | |
| SA-07-G060 | Withdrawn | |
| SA-15-G060 | Withdrawn | |
| SA-10-G060 | Withdrawn |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 |
|---|---|
| K151076 | 2015-05-22 |
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.