Emerald
Dx Emerald Guidewires OEM Diameter .035 in Length 150 cm
10manufacturers in China registered for this device type
60catalogue numbers in this listing
1recall
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 | Cordis US Corp., United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K935170 |
| Record published | 2024-02-07 |
| Record revised | 2025-09-05 (version 3) |
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 | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 502456 | In distribution | |
| 502521E | In distribution | |
| 502536 | In distribution | |
| 502560 | In distribution | |
| 502571 | In distribution | |
| 502454 | In distribution | |
| 502553 | In distribution | |
| 502571H | In distribution | |
| 502453E | In distribution | |
| 502524 | In distribution | |
| 502534 | In distribution | |
| 502548 | In distribution | |
| 503521E | In distribution | |
| 502581A | In distribution | |
| 502521H | In distribution | |
| 502452 | In distribution | |
| 502555 | In distribution | |
| 502726 | In distribution | |
| 502585 | In distribution | |
| 502717 | In distribution | |
| 502520 | In distribution | |
| 502453F | In distribution | |
| 502588 | In distribution | |
| 502587 | In distribution | |
| 502554 | In distribution | |
| 502581 | In distribution | |
| 502580 | In distribution | |
| 502585F | In distribution | |
| 502701 | In distribution | |
| 502731 | In distribution | |
| 502570A | In distribution | |
| 502453 | In distribution | |
| 502520H | In distribution | |
| 502558 | In distribution | |
| 502455 | In distribution | |
| 502521F | In distribution | |
| 502544 | In distribution | |
| 502584F | In distribution | |
| 502549 | In distribution | |
| 502531 | In distribution | |
| 502563 | In distribution | |
| 502530 | In distribution | |
| 502442E | In distribution | |
| 502733 | In distribution | |
| 502739H | In distribution | |
| 502570 | In distribution | |
| 502542E | In distribution | |
| 503521F | In distribution | |
| 502584 | In distribution | |
| 502526 | In distribution | |
| 502576 | In distribution | |
| 502535 | In distribution | |
| 502571A | In distribution | |
| 502728 | In distribution | |
| 502735 | In distribution | |
| 502520F | In distribution | |
| 502703 | In distribution | |
| 502541 | In distribution | |
| 502542 | In distribution | |
| 502522 | 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-08-25 | Not classified | Process control | Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number). | 145 units | 2010-08-11 |
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.