Navilyst
Vascular Guidewire, Nitinol w/ Hydrophilic Coating, Straight, Radiopaque Tip
10manufacturers in China registered for this device type
51catalogue numbers in this listing
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 | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Record published | 2016-09-19 |
| Record revised | 2023-08-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10, box of 5, box of 3 |
| Sizes | Outer diameter 0.018 to 0.038 in; length 60 to 260 cm; length 150 ft |
| Distribution end date | 2022-05-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45747 | Length 145 cm | In distribution |
| 97000402 | Outer Diameter 0.038 in | In distribution |
| 97000405 | Outer Diameter 0.035 in | In distribution |
| 97000113 | Length 60 cm | In distribution |
| 97000235 | Length 145 cm | In distribution |
| 97000107 | Length 145 cm | In distribution |
| 97000303 | Length 145 cm | In distribution |
| 96000604 | Outer Diameter 0.035 in | In distribution |
| 97000601 | Outer Diameter 0.035 in | In distribution |
| 97000211 | Length 175 cm | In distribution |
| 97000401 | Outer Diameter 0.035 in | In distribution |
| 97000507 | Outer Diameter 0.032 in | In distribution |
| 97000307 | Length 145 cm | In distribution |
| 97000302 | Outer Diameter 0.038 in | In distribution |
| 96000301 | Outer Diameter 0.035 in | In distribution |
| 97000508 | Outer Diameter 0.038 in | In distribution |
| 96000218 | Length 150 cm | In distribution |
| 96000304 | Length 150 ft | In distribution |
| 96000302 | Length 150 cm | In distribution |
| 97000602 | Length 145 cm | In distribution |
| 97000108 | Length 60 cm | In distribution |
| 97000103 | Outer Diameter 0.038 in | In distribution |
| 45746 | Length 70 cm | In distribution |
| 97000406 | Outer Diameter 0.038 in | In distribution |
| 97000217 | Outer Diameter 0.035 in | In distribution |
| 97000205 | Length 145 cm | In distribution |
| 97000501 | Outer Diameter 0.035 in | In distribution |
| 97000503 | Outer Diameter 0.038 in | In distribution |
| 97000206 | Outer Diameter 0.038 in | Withdrawn |
| 96000303 | Outer Diameter 0.035 in | Withdrawn |
| 97000222 | Length 145 cm | Withdrawn |
| 97000104 | Outer Diameter 0.038 in | Withdrawn |
| 97000202 | Length 145 cm | Withdrawn |
| 97000109 | Outer Diameter 0.025 in | Withdrawn |
| 97000101 | Length 145 cm | Withdrawn |
| 96000217 | Outer Diameter 0.035 in | Withdrawn |
| 97000203 | Outer Diameter 0.035 in | Withdrawn |
| 96000603 | Length 150 cm | Withdrawn |
| 97000106 | Length 145 cm | Withdrawn |
| 97000216 | Length 145 cm | Withdrawn |
| 97000112 | Outer Diameter 0.038 in | Withdrawn |
| 97000232 | Outer Diameter 0.032 in | Withdrawn |
| 97000504 | Length 145 cm | Withdrawn |
| 97000102 | Outer Diameter 0.035 in | Withdrawn |
| 97000201 | Length 175 cm | Withdrawn |
| 97000233 | Length 145 cm | Withdrawn |
| 97000208 | Length 145 cm | Withdrawn |
| 97000219 | Outer Diameter 0.035 in | Withdrawn |
| 97000505 | Outer Diameter 0.035 in | Withdrawn |
| 97000210 | Outer Diameter 0.035 in | Withdrawn |
| 97000105 | Length 145 cm | 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 |
| 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
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.