Emeryglide
EmeryGlide model EG18008901 is a guidewire intended to direct a catheter to an anatomical location in the vasculatory system. The filing describes a sterile, disposable wire for introducing…
EmeryGlide model EG18008901 is a guidewire intended to direct a catheter to an anatomical location in the vasculatory system.
The filing describes a sterile, disposable wire for introducing or placing diagnostic and interventional devices.
Listed Item
EmeryGlide™ is a sterile, disposable guidewire for the introduction and/or placement of diagnostic or interventional devices. EmeryGlide™ is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The distal tip of EmeryGlide™ is marked with discrete ring markers for MRI and X-Ray visibility and comes in an angled configuration. EmeryGlide™ is supplied sterile and non-pyrogenic. EmeryGlide™’s diameter is 0.035” (0.89 mm).
Construction and Configuration
Its construction is described as a glass-fiber and polymer core composite, an aramid-fiber mantle and a PTFE outer extrusion. The listed model is 180 cm long with a shaped angled tip.
Who Else Makes It
Concentrated in Beijing (4), Jiangsu (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | NANO4IMAGING Gmbh, Germany |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Manufacturer |
| 510(k) | K253262 |
| Record published | 2026-07-23 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Shelf box, shipper box of 5 |
| Sizes | Guidewire diameter 0.035 in; guidewire length 180 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EG18008901 | Guidewire Diameter 0.035 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| Cook | Cook Incorporated | 410 |
| Guidewire | Argon Medical Devices, Inc. | 173 |
| Medline Industries, Inc. | Medline Industries, Inc. | 151 |
| Guidewire | Galt Medical Corp. | 144 |
| Amplatz | Cook Incorporated | 128 |
| InQwire® | Merit Medical Systems, Inc. | 120 |
| Angiographic Guide Wire | Medtronic, Inc. | 94 |
| Glidewire | Terumo Corp. | 83 |
| Starter™ Guidewire | Lake Region Medical Limited | 82 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
Showing 12 of 525. All products under Wire, Guide, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253262 | 2026-03-06 |
| K173423 | 2017-11-17 |
| K160594 | 2016-11-22 |
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.