Glidewire
GLIDEWIRE GT Guide Wire
10manufacturers in China registered for this device type
83catalogue 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 | 2024-12-23 (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 |
| Storage | Special storage condition: Fragile.Keep away from rain. Keep away from sunlight. |
| Packaging | Carton of 5, shelfbox of 5 |
| Sizes | Length 80 to 450 cm; outer diameter 0.41 to 0.97 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GR1804 | Flexible Tip Length: 3cm | In distribution |
| RG*GW1618SP | Outer Diameter 0.41 mm | In distribution |
| GR3545 | Outer Diameter 0.89 mm | In distribution |
| GR3520 | Flexible Tip Length: 1cm | In distribution |
| GS3802 | Outer Diameter 0.97 mm | In distribution |
| GR3807 | Flexible Tip Length: 8cm | In distribution |
| GR3509 | Length 260 cm | In distribution |
| GS3507 | Outer Diameter 0.89 mm | In distribution |
| GR3508 | Length 180 cm | In distribution |
| GS3804 | Length 80 cm | In distribution |
| EWS4035 | Outer Diameter 0.89 mm | In distribution |
| GR2504 | Flexible Tip Length: 3cm | In distribution |
| GR1805 | Outer Diameter 0.46 mm | In distribution |
| GS3543 | Outer Diameter 0.89 mm | In distribution |
| GR2501 | Flexible Tip Length: 3cm | In distribution |
| GE3501 | Length 150 cm | In distribution |
| RG*ES1818SP | Outer Diameter 0.46 mm | In distribution |
| GR3536 | Length 350 cm | In distribution |
| GS3540 | Outer Diameter 0.89 mm | In distribution |
| GR3504 | Flexible Tip Length: 3cm | In distribution |
| RG*GA1818SA | 45 Degree Angle | In distribution |
| GS3539 | Length 400 cm | In distribution |
| RG*GE1818SP | STANDARD | In distribution |
| GR3515 | Length 150 cm | In distribution |
| GE3502 | Length 180 cm | In distribution |
| UWS2038 | Flexible Tip Length: 5cm | In distribution |
| GS3803 | Length 180 cm | In distribution |
| GR3535 | Length 350 cm | In distribution |
| GR3502 | Flexible Tip Length: 8cm | In distribution |
| RG*ES1818SA | Shapeable | In distribution |
| UWS5038 | Length 150 cm | In distribution |
| GS3502 | Length 150 cm | In distribution |
| GS3511 | Length 150 cm | In distribution |
| GS3535 | Length 350 cm | In distribution |
| UWR1032 | Length 150 cm | In distribution |
| GR3534 | Outer Diameter 0.89 mm | In distribution |
| GR3526 | Outer Diameter 0.89 mm | In distribution |
| GS3508 | Flexible Tip Length: 3cm | In distribution |
| GR2505 | Length 180 cm | In distribution |
| GR3806 | Length 150 cm | In distribution |
| GR3540 | Outer Diameter 0.89 mm | In distribution |
| GS1804 | Outer Diameter 0.51 mm | In distribution |
| RG*GW1820SP | STANDARD | In distribution |
| UWS2035 | Length 150 cm | In distribution |
| GR3538 | Outer Diameter 0.89 mm | In distribution |
| GS3533 | Length 350 cm | In distribution |
| GR3802 | Length 150 cm | In distribution |
| GR3544 | Outer Diameter 0.89 mm | In distribution |
| GR3513 | Length 80 cm | In distribution |
| RG*GE1818SA | Length 180 cm | In distribution |
| GR3533 | Outer Diameter 0.89 mm | In distribution |
| GS3509 | Outer Diameter 0.89 mm | In distribution |
| UWR6035 | Length 150 cm | In distribution |
| GS3536 | Outer Diameter 0.89 mm | In distribution |
| RG*GA1818SP | STANDARD | In distribution |
| GR1807 | Outer Diameter 0.46 mm | In distribution |
| GS3541 | Length 400 cm | In distribution |
| RG*ES1820SP | STANDARD | In distribution |
| UWR2032 | Outer Diameter 0.81 mm | In distribution |
| GS3546 | Outer Diameter 0.89 mm | In distribution |
| GR3543 | Outer Diameter 0.89 mm | In distribution |
| GS3501 | Flexible Tip Length: 3cm | In distribution |
| GS3505 | Outer Diameter 0.89 mm | In distribution |
| GR3541 | Length 400 cm | In distribution |
| UWR1025 | Flexible Tip Length: 3cm | In distribution |
| UWR6038 | Flexible Tip Length: 3cm | In distribution |
| RG*GW1818SA | Double Angle | In distribution |
| GS3544 | Outer Diameter 0.89 mm | In distribution |
| RG*GW1818SP | DOUBLE ANGLE | In distribution |
| GR3510 | Length 150 cm | In distribution |
| GR3501 | Outer Diameter 0.89 mm | In distribution |
| GS3806 | Flexible Tip Length: 5cm | In distribution |
| EWS4525 | Flexible Tip Length: 3cm | In distribution |
| GR3546 | Outer Diameter 0.89 mm | In distribution |
| GR3519 | Flexible Tip Length: 1cm | In distribution |
| GR3507 | Outer Diameter 0.89 mm | In distribution |
| GR3539 | Length 400 cm | In distribution |
| GS1803 | Flexible Tip Length: 3cm | In distribution |
| GR3525 | Flexible Tip Length: 3cm | In distribution |
| GS3506 | Outer Diameter 0.89 mm | In distribution |
| EWSS5425 | Outer Diameter 0.64 mm | In distribution |
| RG*ES1618SP | Length 180 cm | In distribution |
| GR3522 | Length 180 cm | 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 |
| Starter™ Guidewire | Lake Region Medical Limited | 82 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
| INT, FirstWire | Shanghai Kindly Medical Instruments Co., Ltd. | 65 |
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.