Headliner
HEADLINER Hydrophilic Coated Guidewire
10manufacturers in China registered for this device type
11catalogue numbers in this listing
15510(k) clearances naming this product code
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 | Terumo Corp., Japan |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-09 |
| Record revised | 2018-03-29 (version 2) |
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 |
| Storage | Special storage condition: FRAGILE. KEEP AWAY FROM RAIN. KEEP AWAY FROM SUNLIGHT. LIMIT STACK TO10. |
| Packaging | Carton of 5 |
| Sizes | Outer diameter 0.3 to 0.41 mm; length 200 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GM1422 | 45 degree Shapeable type | In distribution |
| GM1623 | Length 200 cm | In distribution |
| GM1421 | Outer Diameter 0.36 mm | In distribution |
| GM1221 | Outer Diameter 0.30 mm | In distribution |
| GM1223 | Outer Diameter 0.30 mm | In distribution |
| GM1622 | 90 degree ANGLED | In distribution |
| GM1621 | Length 200 cm | In distribution |
| GM1624 | Outer Diameter 0.41 mm | In distribution |
| GM1423 | Outer Diameter 0.36 mm | In distribution |
| GM1224 | DOUBLE ANGLE | In distribution |
| GM1222 | 90 degree ANGLED | 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 |
|---|---|
| K240818 | 2024-11-26 |
| K240859 | 2024-08-21 |
| K170417 | 2017-09-15 |
| K122590 | 2013-03-01 |
| K080563 | 2008-03-20 |
| K063695 | 2007-04-27 |
| K063372 | 2007-01-19 |
| K961445 | 1996-07-09 |
| K955801 | 1996-02-02 |
| K953533 | 1995-10-18 |
| K925852 | 1993-06-10 |
| K924202 | 1992-11-23 |
| K913074 | 1991-11-05 |
| K910969 | 1991-05-16 |
| K863138 | 1986-11-20 |
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 |
|---|---|---|---|---|---|
| 2011-06-03 | Not classified | Device Design | Baloon catheter guidewires may become uncoiled during angioplasty procedures. | 70 units | 2011-07-27 |
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.