Guidewire
Guidewire 18/40/NIT/Mandrel w/Palladium Coil/Straight
10manufacturers in China registered for this device type
173catalogue numbers in this listing
1510(k) clearance
40recalls on this code
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 | Argon Medical Devices, Inc., United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-12 |
| Record revised | 2026-05-25 (version 8) |
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, manufacturing date |
| Packaging | Box of 10, box of 50 |
| Distribution end date | 2025-01-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 395654 | .035″ x 50cm | In distribution |
| 395271 | .035″ x 40cm | In distribution |
| 393999 | .035″ x 180cm | In distribution |
| 395451 | .018″ x 40cm | In distribution |
| 395536 | .021″ x 25cm | In distribution |
| 395217 | .038″ x 40cm | In distribution |
| 395722 | .035″ x 200cm | In distribution |
| 395680 | .035″ x 45cm | In distribution |
| 395406 | .021″ x 260cm | In distribution |
| 395943 | .018″ x 65cm | In distribution |
| 395610 | .032″ x 40cm | In distribution |
| 395839 | .038″ x 260cm | In distribution |
| 395370 | .038″ x 260cm | In distribution |
| 395798 | .035″ x 70cm | In distribution |
| 395539 | .032″ x 65cm | In distribution |
| 388282 | .035″ x 150cm | In distribution |
| 393182 | .035″ x 150cm | In distribution |
| 395622 | .032″ x 260cm | In distribution |
| 395559 | .025″ x 150cm | In distribution |
| 390282 | .035″ x 150cm | In distribution |
| 395687 | .035″ x 150cm | In distribution |
| 395513 | .021″ x 40cm | In distribution |
| 395787 | .035″ x 150cm | In distribution |
| 395312 | .035″ x 150cm | In distribution |
| 395077 | .025″ x 260cm | In distribution |
| 395125 | .018″ x 45cm | In distribution |
| 395930E | .035″ x 150cm | In distribution |
| 393282 | .035″ x 150cm | In distribution |
| 395170 | .035″ x 180cm | In distribution |
| 395794 | .035″ x 260cm | In distribution |
| 395585 | .025″ x 260cm | In distribution |
| 395234 | .038″ x 150cm | In distribution |
| 395899 | .035″ x 65cm | In distribution |
| 395206 | .025″ x 40cm | In distribution |
| 395703 | .035″ x 200cm | In distribution |
| 395282 | .035″ x 150cm | In distribution |
| 395613 | .032″ x 125cm | In distribution |
| 395768 | .035″ x 175cm | In distribution |
| A395231 | .035″ x 150cm | In distribution |
| 395600 | .032″ x 150cm | In distribution |
| 395420 | .025″ x 150cm | In distribution |
| 395284 | .038″ x 150cm | In distribution |
| 395225 | .025″ x 150cm | In distribution |
| 388794 | .035″ x 260cm | In distribution |
| A395312 | .035″ x 150cm | In distribution |
| 395126 | .018″ x 40cm | In distribution |
| 395855 | .038″ x 50cm | In distribution |
| 395200 | .018″ x 80cm | In distribution |
| 395231 | .035″ x 150cm | In distribution |
| 395573 | .025″ x 40cm | In distribution |
| 395279 | .025″ x 125cm | In distribution |
| 395369 | .035″ x 260cm | In distribution |
| 395945 | .018″ x 100cm | In distribution |
| 395523 | .021″ x 150cm | In distribution |
| 395367 | .025″ x 260cm | In distribution |
| 395919 | .035″ x 150cm | In distribution |
| 395770 | .035″ x 50cm | In distribution |
| 395872 | .018″ x 65cm | Withdrawn |
| 395345 | .035″ x 150cm | Withdrawn |
| 395297 | .035″ x 100cm | Withdrawn |
| 388768 | .035″ x 175cm | Withdrawn |
| 388273 | .035″ x 150cm | Withdrawn |
| 395128 | .018″ x 125cm | Withdrawn |
| A395722 | .035″ x 200cm | Withdrawn |
| A395559 | .025″ x 150cm | Withdrawn |
| 395508 | .021″ x 50cm | Withdrawn |
| 393187 | .038″ x 175cm | Withdrawn |
| 390186 | .035″ x 175cm | Withdrawn |
| 395470 | .018″ x 150cm | Withdrawn |
| 390284 | .038″ x 150cm | Withdrawn |
| A395900 | .032″ x 150cm | Withdrawn |
| A395787 | .035″ x 150cm | Withdrawn |
| 395368 | .032″ x 260cm | Withdrawn |
| 395993 | .035″ x 150cm | Withdrawn |
| 395884 | .028″ x 150cm | Withdrawn |
| A395600 | .032″ x 150cm | Withdrawn |
| 395962 | .028″ x 40cm | Withdrawn |
| 395835 | .038″ x 60cm | Withdrawn |
| 395289 | .035″ x 150cm | Withdrawn |
| 395224 | .025″ x 125cm | Withdrawn |
| 395268 | .021″ x 100cm | Withdrawn |
| 395266 | .038″ x 150cm | Withdrawn |
| 395350 | .035″ x 180cm | Withdrawn |
| 395384 | .035″ x 150cm | Withdrawn |
| 395454 | .018″ x 40cm | Withdrawn |
| 395320 | .035″ x 150cm | Withdrawn |
| 395201 | .018″ x 100cm | Withdrawn |
| 395820 | .038″ x 50cm | Withdrawn |
| 395278 | .025″ x 100cm | Withdrawn |
| 395692 | .035″ x 65cm | Withdrawn |
| 395228 | .032″ x 150cm | Withdrawn |
| 395208 | .025″ x 125cm | Withdrawn |
| 395353 | .038″ x 150cm | Withdrawn |
| 395900 | .032″ x 150cm | Withdrawn |
| 395989 | .028″ x 50cm | Withdrawn |
| 395280 | .035″ x 150cm | Withdrawn |
| 395204 | .021″ x 100cm | Withdrawn |
| 395863 | .038″ x 150cm | Withdrawn |
| 395541 | .021″ x 50cm | Withdrawn |
| 395817 | .038″ x 200cm | Withdrawn |
| 395711 | .035″ x 75cm | Withdrawn |
| 395875 | .025″ x 65cm | Withdrawn |
| 395112 | .035″ x 150cm | Withdrawn |
| 395931 | .032″ x 150cm | Withdrawn |
| 388301 | .035″ x 150cm | Withdrawn |
| 395258 | .035″ x 150cm | Withdrawn |
| 395746 | .035″ x 75cm | Withdrawn |
| 395868 | .035″ x 80cm | Withdrawn |
| 395844 | .038″ x 70cm | Withdrawn |
| A395284 | .038″ x 150cm | Withdrawn |
| 395382 | .035″ x 150cm | Withdrawn |
| 395415 | .025″ x 65cm | Withdrawn |
| 395721 | .035″ x 145cm | Withdrawn |
| 395213 | .035″ x 40cm | Withdrawn |
| 395752 | .035″ x 75cm | Withdrawn |
| 395501 | .021″ x 150cm | Withdrawn |
| 393186 | .035″ x 175cm | Withdrawn |
| 393184 | .038″ x 150cm | Withdrawn |
| 395961 | .028″ x 150cm | Withdrawn |
| 395309 | .032″ x 150cm | Withdrawn |
| 395352 | .035″ x 150cm | Withdrawn |
| 395998 | .035″ x 50cm | Withdrawn |
| A395282 | .035″ x 150cm | Withdrawn |
| 395933C | .038″ x 150cm | Withdrawn |
| 395183 | .035″ x 150cm | Withdrawn |
| 395504 | .021″ x 125cm | Withdrawn |
| 395203 | .021″ x 80cm | Withdrawn |
| 395073 | .035″ x 260cm | Withdrawn |
| A395369 | .035″ x 260cm | Withdrawn |
| 395980 | .017″ x 150cm | Withdrawn |
| 395333 | .038″ x 260cm | Withdrawn |
| 388300 | .035″ x 150cm | Withdrawn |
| 395708 | .035″ x 150cm | Withdrawn |
| 395730 | .018″ x 50cm | Withdrawn |
| 395603 | .032″ x 150cm | Withdrawn |
| 395465 | .018″ x 150cm | Withdrawn |
| 395398 | .035″ x 150cm | Withdrawn |
| 395337 | .035″ x 125cm | Withdrawn |
| 395330 | .038″ x 260cm | Withdrawn |
| 395270 | .025″ x 125cm | Withdrawn |
| 395400 | .025″ x 50cm | Withdrawn |
| 395979 | .015″ x 150cm | Withdrawn |
| 390182 | .035″ x 150cm | Withdrawn |
| 395275 | .038″ x 150cm | Withdrawn |
| 395946 | .021″ x 65cm | Withdrawn |
| 395924 | .038″ x 80cm | Withdrawn |
| 395780 | .035″ x 150cm | Withdrawn |
| 395422 | .025″ x 40cm | Withdrawn |
| 395948 | .021″ x 100cm | Withdrawn |
| A395613 | .032″ x 125cm | Withdrawn |
| 395522 | .021″ x 260cm | Withdrawn |
| A395482 | .035″ x 180cm | Withdrawn |
| 395273 | .035″ x 150cm | Withdrawn |
| 395205 | .021″ x 125cm | Withdrawn |
| 395701 | .035″ x 70cm | Withdrawn |
| 388275 | .038″ x 150cm | Withdrawn |
| 395315 | .038″ x 150cm | Withdrawn |
| 395076 | .025″ x 150cm | Withdrawn |
| 395991 | .030″ x 150cm | Withdrawn |
| 395261 | .038″ x 150cm | Withdrawn |
| 395332 | .032″ x 150cm | Withdrawn |
| 395457 | .018″ x 150cm | Withdrawn |
| 395656 | .035″ x 200cm | Withdrawn |
| 395469 | .018″ x 260cm | Withdrawn |
| 395518 | .021″ x 80cm | Withdrawn |
| 395537 | .021″ x 40cm | Withdrawn |
| 395510 | .021″ x 40cm | Withdrawn |
| 395874 | .021″ x 65cm | Withdrawn |
| 395281 | .035″ x 125cm | Withdrawn |
| 395732 | .021″ x 50cm | Withdrawn |
| 388284 | .038″ x 150cm | Withdrawn |
| 395212 | .032″ x 150cm | Withdrawn |
| 395509 | .021″ x 150cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| Cook | Cook Incorporated | 410 |
| 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 |
| 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 |
|---|---|
| K160785 | 2016-12-08 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-12-04 | Class I | Employee error | The stiffness of the soft end of the guidewire caused tissue perforation. | 1690 units | 2024-04-01 |
| 2019-12-04 | Class I | Employee error | The stiffness of the soft end of the guidewire caused tissue perforation. | 1190 units | 2024-04-01 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 500 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 500 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 50 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 72 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 393 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 220 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 20 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 13 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 7,885 | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 100 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 55 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 30 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 5,521 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 300 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 800 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 1,285 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 325 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 30 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 401 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 130 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 65 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 75 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 1,749 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 4 | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 700 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 1,400 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 2,600 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 3 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 25 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 45 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 750 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 1,566 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 7,160 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 18 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 427 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 100 units | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 275 | 2010-01-07 |
| 2009-02-26 | Not classified | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | 3,300 units | 2010-01-07 |
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.