GuideRight™
69 catalogue numbers from 404877, listed by St. Jude Medical, United States, under Wire, Guide, Catheter. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
69catalogue numbers in this listing
3510(k) clearances naming this product 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 | St. Jude Medical, United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K770977 |
| Record published | 2015-06-30 |
| Record revised | 2025-12-22 (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, manufacturing date |
| Storage | Special storage condition: STORE IN A COOL, DARK, DRY PLACE. |
| Packaging | Pack of 5 |
| Sizes | Outer diameter 0.53 to 1.65 mm; length 150 to 180 cm; outer diameter 0.025 to 0.035 in |
| Distribution end date | 2018-06-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 404877 | Outer Diameter 0.97 mm | In distribution |
| 404581 | Outer Diameter 0.97 mm | In distribution |
| 404577 | Outer Diameter 0.89 mm | In distribution |
| 404570 | Outer Diameter 0.89 mm | In distribution |
| 404560 | Outer Diameter 0.81 mm | In distribution |
| 404575 | Outer Diameter 0.89 mm | In distribution |
| 404574 | Outer Diameter 0.89 mm | In distribution |
| 404610 | Outer Diameter 0.97 mm | In distribution |
| 404847 | Outer Diameter 0.64 mm | In distribution |
| 404844 | Outer Diameter 0.89 mm | In distribution |
| 404874 | Outer Diameter 0.97 mm | In distribution |
| 404841 | Outer Diameter 0.89 mm | In distribution |
| 404848 | Outer Diameter 0.032 in | In distribution |
| 405020 | Length 150 cm | In distribution |
| 404557 | Outer Diameter 0.97 mm | In distribution |
| 404611 | Outer Diameter 0.97 mm | In distribution |
| 404876 | Outer Diameter 0.97 mm | In distribution |
| 405050 | Outer Diameter 0.89 mm | In distribution |
| 404840 | Outer Diameter 0.89 mm | In distribution |
| 405022 | Outer Diameter 0.97 mm | In distribution |
| 404968 | Outer Diameter 0.97 mm | In distribution |
| Guidewires | Outer Diameter 0.81 mm | In distribution |
| 404617 | Outer Diameter 0.97 mm | In distribution |
| 404949 | Outer Diameter 0.89 mm | In distribution |
| 405016 | Length 150 cm | In distribution |
| 404878 | Outer Diameter 0.81 mm | In distribution |
| 404578 | Outer Diameter 0.89 mm | In distribution |
| 404552 | Outer Diameter 0.81 mm | In distribution |
| 404571 | Outer Diameter 0.89 mm | In distribution |
| 404582 | Outer Diameter 0.97 mm | In distribution |
| 404843 | Outer Diameter 0.89 mm | In distribution |
| 404998 | Length 150 cm | In distribution |
| 404555 | Outer Diameter 0.89 mm | In distribution |
| 404568 | Outer Diameter 0.64 mm | In distribution |
| 404584 | Outer Diameter 0.53 mm | In distribution |
| 404586 | Outer Diameter 0.64 mm | In distribution |
| 404580 | Outer Diameter 0.89 mm | In distribution |
| 404576 | Outer Diameter 0.89 mm | In distribution |
| 404579 | Outer Diameter 0.89 mm | Withdrawn |
| 404613 | Outer Diameter 0.97 mm | Withdrawn |
| 404969 | Outer Diameter 0.97 mm | Withdrawn |
| 404999 | Outer Diameter 0.89 mm | Withdrawn |
| 404587 | Outer Diameter 0.028 in | Withdrawn |
| 405052 | Outer Diameter 0.89 mm | Withdrawn |
| 404873 | Outer Diameter 0.97 mm | Withdrawn |
| 404553 | Outer Diameter 0.97 mm | Withdrawn |
| 404612 | Outer Diameter 0.97 mm | Withdrawn |
| 404572 | Outer Diameter 0.89 mm | Withdrawn |
| 404559 | Outer Diameter 0.89 mm | Withdrawn |
| 404551 | Outer Diameter 0.64 mm | Withdrawn |
| 404554 | Outer Diameter 0.97 mm | Withdrawn |
| 404846 | Outer Diameter 0.53 mm | Withdrawn |
| 404550 | Outer Diameter 0.53 mm | Withdrawn |
| 405013 | Outer Diameter 0.97 mm | Withdrawn |
| 404585 | Outer Diameter 0.025 in | Withdrawn |
| 404618 | Outer Diameter 1.65 mm | Withdrawn |
| 404583 | Outer Diameter 0.76 mm | Withdrawn |
| 405051 | Outer Diameter 0.89 mm | Withdrawn |
| 405017 | Outer Diameter 0.89 mm | Withdrawn |
| 404948 | Outer Diameter 0.89 mm | Withdrawn |
| 405021 | Outer Diameter 0.89 mm | Withdrawn |
| 404870 | Outer Diameter 0.97 mm | Withdrawn |
| 404616 | Outer Diameter 0.97 mm | Withdrawn |
| 404573 | Outer Diameter 0.89 mm | Withdrawn |
| 405018 | Outer Diameter 0.89 mm | Withdrawn |
| 405012 | Outer Diameter 0.97 mm | Withdrawn |
| 405015 | Outer Diameter 0.89 mm | Withdrawn |
| 405014 | Outer Diameter 0.89 mm | Withdrawn |
| 404615 | Outer Diameter 0.97 mm | 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 |
| 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 |
|---|---|
| K142254 | 2014-11-13 |
| K100710 | 2010-04-28 |
| K082304 | 2008-08-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Bard Peripheral Vascular, Inc. | 510(k) number | 2024-07-10 | Class II | Under Investigation by firm | Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts t | 625 units |
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.