Forté™
20 catalogue numbers from H74934949020, listed by Lake Region Medical Limited, Ireland, under Wire, Guide, Catheter. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
20catalogue numbers in this listing
13510(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 | Lake Region Medical Limited, Ireland |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K011968 |
| Record published | 2016-10-31 |
| Record revised | 2018-07-06 (version 3) |
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, dry, dark place. |
| Packaging | Pack of 5 |
| Sizes | Outer diameter 0.014 in; length 185 to 300 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H74934949020 | Outer Diameter.014 in | In distribution |
| H7493494905J0 | Outer Diameter.014 in | In distribution |
| H7493494902J0 | Outer Diameter.014 in | In distribution |
| H7493494908J0 | Outer Diameter.014 in | In distribution |
| H7493494904J0 | Outer Diameter.014 in | In distribution |
| H74934949030 | Outer Diameter.014 in | In distribution |
| H74934949100 | Outer Diameter.014 in | In distribution |
| H7493494907J0 | Outer Diameter.014 in | In distribution |
| H7493494901J0 | Outer Diameter.014 in | In distribution |
| H74934949070 | Outer Diameter.014 in | In distribution |
| H74934949060 | Outer Diameter.014 in | In distribution |
| H7493494906J0 | Outer Diameter.014 in | In distribution |
| H7493494910J0 | Outer Diameter.014 in | In distribution |
| H74934949040 | Outer Diameter.014 in | In distribution |
| H74934949090 | Outer Diameter.014 in | In distribution |
| H7493494909J0 | Outer Diameter.014 in | In distribution |
| H7493494903J0 | Outer Diameter.014 in | In distribution |
| H74934949050 | Outer Diameter.014 in | In distribution |
| H74934949080 | Outer Diameter.014 in | In distribution |
| H74934949010 | Outer Diameter.014 in | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253746 | 2026-03-19 |
| K242824 | 2024-12-06 |
| K221575 | 2022-10-07 |
| K211741 | 2021-11-22 |
| K160643 | 2016-10-18 |
| K151244 | 2015-06-11 |
| K140536 | 2014-12-17 |
| K142393 | 2014-11-25 |
| K133155 | 2014-04-07 |
| K140485 | 2014-03-27 |
| K130798 | 2013-08-23 |
| K112381 | 2011-11-03 |
| K111288 | 2011-08-02 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | 510(k) number | 2009-05-12 | Not classified | Process control | Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since | Total of 5 boxes (5 units /box) , | 2011-12-11 |
| Boston Scientific Corporation | 510(k) number | 2009-05-12 | Not classified | Process control | Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since | Total of 4 boxes (5 units /box). | 2011-12-11 |
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.