Prelude®
4 catalogue numbers from 10884450208257, listed by Merit Medical Systems, Inc., United States, under Wire, Guide, Catheter. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
4catalogue numbers in this listing
22510(k) clearances naming this product code
9recalls 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 | Merit Medical Systems, 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, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2025-05-12 (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 |
| Packaging | Pack of 14 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10884450208257 | Guide Wire Diameter-0.021″ (0.53 mm) | 5 | In distribution |
| 10884450208271 | Guide Wire Diameter-0.025″ (0.64 mm) | 5 | In distribution |
| 10884450208240 | Guide Wire Diameter-0.021″ (0.53 mm) | 5 | In distribution |
| 10884450208264 | Guide Wire Diameter-0.025″ (0.64 mm) | 5 | 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 |
|---|---|
| K241521 | 2024-12-10 |
| K230418 | 2023-10-28 |
| K201595 | 2020-10-14 |
| K170532 | 2017-07-21 |
| K170933 | 2017-06-22 |
| K170700 | 2017-04-06 |
| K163575 | 2017-03-03 |
| K142051 | 2014-12-17 |
| K141295 | 2014-12-16 |
| K140608 | 2014-09-12 |
| K133230 | 2013-12-12 |
| K131710 | 2013-07-29 |
| K130588 | 2013-04-05 |
| K123609 | 2013-01-16 |
| K122089 | 2012-09-21 |
| K120644 | 2012-09-19 |
| K092303 | 2009-10-27 |
| K072552 | 2007-12-14 |
| K002289 | 2000-10-04 |
| K973708 | 1997-12-19 |
| K936032 | 1994-03-15 |
| K921702 | 1992-09-21 |
Recalls
3 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 | Closed |
|---|---|---|---|---|---|
| 2026-05-08 | Class II | Process design | Due to unsealed portions of pouches. | 5,004 | |
| 2014-04-14 | Class II | Process control | Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035″ 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 unit | 186 | 2014-07-17 |
| 2014-04-14 | Class II | Process control | Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035″ 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureat | 173 | 2014-07-17 |
| 2010-06-28 | Not classified | Process control | Guidewires have decreased lubricity at the proximal end, inhibiting proper operation. | 20 units | 2010-10-19 |
| 2010-06-28 | Not classified | Process control | Guidewires have decreased lubricity at the proximal end, inhibiting proper operation. | 437 units | 2010-10-19 |
| 2010-06-28 | Not classified | Process control | Guidewires have decreased lubricity at the proximal end, inhibiting proper operation. | 199 units | 2010-10-19 |
| 2010-06-28 | Not classified | Process control | Guidewires have decreased lubricity at the proximal end, inhibiting proper operation. | 40 units | 2010-10-19 |
| 2010-06-28 | Not classified | Process control | Guidewires have decreased lubricity at the proximal end, inhibiting proper operation. | 140 units | 2010-10-19 |
| 2010-06-28 | Not classified | Process control | Guidewires have decreased lubricity at the proximal end, inhibiting proper operation. | 128 units | 2010-10-19 |
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.