Guidewire
144 catalogue numbers from SGW-022-33, listed by Galt Medical Corp., United States, under Wire, Guide, Catheter. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
144catalogue numbers in this listing
4510(k) clearances naming this product code
2recalls 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 | Galt Medical Corp., United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2017-07-03 |
| Record revised | 2026-05-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Shelf box of 5, shipper box of 25, shipper box of 50, shelf box of 10, shelf of 5, shipper of 25 |
| Sizes | Outer diameter 0.008 to 0.038 in |
| Distribution end date | 2021-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SGW-022-33 | Outer Diameter 0.018 in | In distribution |
| SGW-038-03 | Outer Diameter 0.025 in | In distribution |
| SGW-038-08 | Outer Diameter 0.018 in | In distribution |
| SGW-073-02 | Outer Diameter 0.014 in | In distribution |
| SGW-051-03 | Outer Diameter 0.008 in | In distribution |
| SGW-035-07 | Outer Diameter 0.035 in | In distribution |
| SGW-071-01 | Outer Diameter 0.014 in | In distribution |
| SGW-019-17 | Outer Diameter 0.018 in | In distribution |
| SGW-066-07 | Outer Diameter 0.030 in | In distribution |
| SGW-056-04 | Outer Diameter 0.018 in | In distribution |
| SGW-038-02 | Outer Diameter 0.018 in | In distribution |
| SGW-060-05 | Outer Diameter 0.014 in | In distribution |
| SGW-075-01 | Outer Diameter 0.013 in | In distribution |
| SGW-035-05 | Outer Diameter 0.035 in | In distribution |
| SGW-004-06 | Outer Diameter 0.035 in | In distribution |
| SGW-071-02 | Outer Diameter 0.014 in | In distribution |
| SGW-051-07 | Outer Diameter 0.010 in | In distribution |
| SGW-060-12 | Outer Diameter 0.018 in | In distribution |
| SGW-035-00 | Outer Diameter 0.035 in | In distribution |
| SGW-038-05 | Outer Diameter 0.014 in | In distribution |
| SGW-072-01 | Outer Diameter 0.014 in | In distribution |
| SGW-022-11 | Outer Diameter 0.018 in | In distribution |
| SGW-060-09 | Outer Diameter 0.018 in | In distribution |
| SGW-019-19 | Outer Diameter 0.014 in | In distribution |
| SGW-056-62 | Outer Diameter 0.014 in | In distribution |
| SGW-056-03 | Outer Diameter 0.018 in | In distribution |
| SGW-074-00 | Outer Diameter 0.014 in | In distribution |
| SGW-065-00 | Outer Diameter 0.018 in | In distribution |
| SGW-061-15 | Outer Diameter 0.038 in | In distribution |
| SGW-064-40 | Outer Diameter 0.014 in | In distribution |
| SGW-015-08 | Outer Diameter 0.018 in | In distribution |
| SGW-011-20 | Outer Diameter 0.035 in | In distribution |
| SGW-022-13 | Outer Diameter 0.018 in | In distribution |
| SGW-015-03 | Outer Diameter 0.018 in | In distribution |
| SGW-060-06 | Outer Diameter 0.014 in | In distribution |
| SGW-038-04 | Outer Diameter 0.025 in | In distribution |
| SGW-060-04 | Outer Diameter 0.018 in | In distribution |
| SGW-035-24 | Outer Diameter 0.035 in | In distribution |
| SGW-056-73 | Outer Diameter 0.018 in | In distribution |
| SGW-060-13 | Outer Diameter 0.018 in | In distribution |
| SGW-038-06 | Outer Diameter 0.014 in | In distribution |
| SGW-067-00 | Outer Diameter 0.018 in | In distribution |
| SGW-051-08 | Outer Diameter 0.008 in | In distribution |
| SGW-022-69 | Outer Diameter 0.018 in | In distribution |
| VSW-019-48 | Outer Diameter 0.014 in | In distribution |
| SGW-051-06 | Outer Diameter 0.008 in | In distribution |
| SGW-057-07 | Outer Diameter 0.030 in | In distribution |
| SGW-038-00 | Outer Diameter 0.018 in | In distribution |
| SGW-035-04 | Outer Diameter 0.035 in | In distribution |
| SGW-019-40 | Outer Diameter 0.014 in | In distribution |
| SGW-056-75 | Outer Diameter 0.014 in | In distribution |
| SGW-038-01 | Outer Diameter 0.018 in | In distribution |
| SGW-022-16 | Outer Diameter 0.014 in | In distribution |
| SGW-056-02 | Outer Diameter 0.018 in | In distribution |
| SGW-064-67 | Outer Diameter 0.012 in | In distribution |
| SGW-060-07 | Outer Diameter 0.014 in | In distribution |
| SGW-019-30 | Outer Diameter 0.018 in | In distribution |
| SGW-035-02 | Outer Diameter 0.035 in | In distribution |
| SGW-038-13 | Outer Diameter 0.018 in | In distribution |
| SGW-022-15 | Outer Diameter 0.014 in | In distribution |
| SGW-066-08 | Outer Diameter 0.030 in | In distribution |
| SGW-056-14 | Outer Diameter 0.018 in | In distribution |
| SGW-015-14 | Outer Diameter 0.018 in | In distribution |
| SGW-057-08 | Outer Diameter 0.030 in | In distribution |
| SGW-064-31 | Outer Diameter 0.018 in | In distribution |
| SGW-019-31 | Outer Diameter 0.018 in | In distribution |
| SGW-067-01 | Outer Diameter 0.018 in | In distribution |
| SGW-056-60 | Outer Diameter 0.014 in | In distribution |
| SGW-051-09 | Outer Diameter 0.010 in | In distribution |
| SGW-070-72 | Outer Diameter 0.018 in | In distribution |
| SGW-060-03 | Outer Diameter 0.014 in | In distribution |
| SGW-056-61 | Outer Diameter 0.014 in | In distribution |
| SGW-071-03 | Outer Diameter 0.014 in | In distribution |
| SGW-051-04 | Outer Diameter 0.010 in | In distribution |
| SGW-060-10 | Outer Diameter 0.018 in | In distribution |
| SGW-015-02 | Outer Diameter 0.018 in | In distribution |
| SGW-060-01 | Outer Diameter 0.014 in | In distribution |
| SGW-060-02 | Outer Diameter 0.018 in | In distribution |
| SGW-019-32 | Outer Diameter 0.018 in | In distribution |
| SGW-038-14 | Outer Diameter 0.025 in | In distribution |
| SGW-019-14 | Outer Diameter 0.018 in | In distribution |
| SGW-060-11 | Outer Diameter 0.018 in | In distribution |
| SGW-060-08 | Outer Diameter 0.014 in | In distribution |
| SGW-019-52 | Outer Diameter 0.018 in | In distribution |
| SGW-019-34 | Outer Diameter 0.018 in | In distribution |
| SGW-065-01 | Outer Diameter 0.018 in | In distribution |
| SGW-056-69 | Outer Diameter 0.014 in | In distribution |
| SGW-038-07 | Outer Diameter 0.014 in | In distribution |
| SGW-072-00 | Outer Diameter 0.014 in | In distribution |
| SGW-071-00 | Outer Diameter 0.014 in | In distribution |
| SGW-056-01 | Outer Diameter 0.018 in | In distribution |
| SGW-015-15 | Outer Diameter 0.018 in | Withdrawn |
| SGW-056-10 | Outer Diameter 0.018 in | Withdrawn |
| SGW-021-04 | Outer Diameter 0.018 in | Withdrawn |
| SGW-015-07 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-06 | Outer Diameter 0.018 in | Withdrawn |
| SGW-051-02 | Outer Diameter 0.012 in | Withdrawn |
| SGW-055-08 | Outer Diameter 0.018 in | Withdrawn |
| SGW-055-07 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-08 | Outer Diameter 0.018 in | Withdrawn |
| SGW-021-03 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-38 | Outer Diameter 0.018 in | Withdrawn |
| SGW-038-10 | Outer Diameter 0.018 in | Withdrawn |
| SGW-051-01 | Outer Diameter 0.010 in | Withdrawn |
| SGW-055-15 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-28 | Outer Diameter 0.018 in | Withdrawn |
| SGW-056-12 | Outer Diameter 0.018 in | Withdrawn |
| SGW-055-05 | Outer Diameter 0.018 in | Withdrawn |
| SGW-035-08 | Outer Diameter 0.038 in | Withdrawn |
| SGW-056-11 | Outer Diameter 0.018 in | Withdrawn |
| SGW-022-10 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-20 | Outer Diameter 0.014 in | Withdrawn |
| SGW-022-09 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-07 | Outer Diameter 0.018 in | Withdrawn |
| SGW-015-09 | Outer Diameter 0.018 in | Withdrawn |
| SGW-015-23 | Outer Diameter 0.018 in | Withdrawn |
| SGW-004-13 | Outer Diameter 0.038 in | Withdrawn |
| SGW-052-10 | Outer Diameter 0.0165 in | Withdrawn |
| SGW-022-32 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-53 | Outer Diameter 0.018 in | Withdrawn |
| SGW-022-49 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-37 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-41 | Outer Diameter 0.014 in | Withdrawn |
| SGW-019-13 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-22 | Outer Diameter 0.014 in | Withdrawn |
| SGW-056-06 | Outer Diameter 0.018 in | Withdrawn |
| SGW-038-12 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-09 | Outer Diameter 0.018 in | Withdrawn |
| SGW-038-11 | Outer Diameter 0.018 in | Withdrawn |
| SGW-051-00 | Outer Diameter 0.008 in | Withdrawn |
| SGW-015-05 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-10 | Outer Diameter 0.018 in | Withdrawn |
| SGW-055-46 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-36 | Outer Diameter 0.018 in | Withdrawn |
| SGW-022-14 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-18 | Outer Diameter 0.014 in | Withdrawn |
| SGW-038-09 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-12 | Outer Diameter 0.018 in | Withdrawn |
| SGW-021-02 | Outer Diameter 0.018 in | Withdrawn |
| SGW-019-21 | Outer Diameter 0.014 in | Withdrawn |
| SGW-022-36 | Outer Diameter 0.018 in | Withdrawn |
| SGW-052-11 | Outer Diameter 0.0165 in | Withdrawn |
| SGW-019-16 | Outer Diameter 0.018 in | Withdrawn |
| SGW-004-05 | Outer Diameter 0.035 in | Withdrawn |
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 |
| 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 |
|---|---|
| K033542 | 2003-12-05 |
| K031916 | 2003-07-17 |
| K021990 | 2002-07-18 |
| K982559 | 1999-02-01 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-06-26 | Class II | Under Investigation by firm | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. | 114,260 kits |
| 2025-03-27 | Class II | Process control | Due to a potential open seal in the sterile barrier packaging. | 100 guidewires |
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.