Prelude Roadster™
20 catalogue numbers from 00884450532546, listed by Merit Medical Systems, Inc., United States, under Introducer, Catheter. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
20catalogue numbers in this listing
19510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-07-27 |
| Record revised | 2025-05-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450532546 | Guide Wire Diameter-0.038″ (0.97 mm) | In distribution |
| 00884450770757 | Sheath French Size (F)-5F | In distribution |
| 00884450531709 | Guide Wire Diameter-0.035″ (0.89 mm) | In distribution |
| 00884450532324 | Sheath French Size (F)-7F | In distribution |
| 00884450532584 | Sheath French Size (F)-8F | In distribution |
| 00884450532539 | Sheath French Size (F)-7F | In distribution |
| 00884450532560 | Sheath French Size (F)-8F | In distribution |
| 00884450532300 | Sheath French Size (F)-6F | In distribution |
| 00884450532577 | Sheath French Size (F)-8F | In distribution |
| 00884450532553 | Guide Wire Diameter-0.038″ (0.97 mm); Sheath Length (cm)-90 cm (35.4″); Sheath French Size (F)-7F; Guide Wire Diameter-0.038″ (0.97 mm) | In distribution |
| 00884450531716 | Guide Wire Diameter-0.035″ (0.89 mm) | In distribution |
| 00884450770771 | Sheath French Size (F)-6F | In distribution |
| 00884450532140 | Guide Wire Diameter-0.038″ (0.97 mm) | In distribution |
| 00884450531969 | Guide Wire Diameter-0.038″ (0.97 mm); Sheath French Size (F)-6F; Sheath Length (cm)-45 cm (17.7″); Guide Wire Diameter-0.038″ (0.97 mm) | In distribution |
| 00884450770788 | Sheath French Size (F)-6F | In distribution |
| 00884450531945 | Guide Wire Diameter-0.038″ (0.97 mm) | In distribution |
| 00884450531730 | Guide Wire Diameter-0.038″ (0.97 mm) | In distribution |
| 00884450532607 | Guide Wire Diameter-0.038″ (0.97 mm); Sheath Length (cm)-90 cm (35.4″); Guide Wire Diameter-0.038″ (0.97 mm); Sheath French Size (F)-8F | In distribution |
| 00884450532591 | Sheath French Size (F)-8F; Sheath Length (cm)-65 cm (25.6″); Guide Wire Diameter-0.038″ (0.97 mm); Sheath French Size (F)-8F | In distribution |
| 00884450532515 | Sheath Length (cm)-45 cm (17.7″); Guide Wire Diameter-0.038″ (0.97 mm); Sheath French Size (F)-7F; Sheath Length (cm)-45 cm (17.7″) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250909 | 2025-04-25 |
| K223872 | 2023-01-19 |
| K212152 | 2022-01-07 |
| K211405 | 2021-10-04 |
| K173750 | 2018-02-15 |
| K172117 | 2017-09-11 |
| K170668 | 2017-04-05 |
| K152381 | 2015-10-30 |
| K152116 | 2015-08-27 |
| K150257 | 2015-06-19 |
| K143255 | 2015-04-09 |
| K140543 | 2014-10-16 |
| K140513 | 2014-07-09 |
| K132720 | 2014-02-12 |
| K132164 | 2013-09-17 |
| K122190 | 2012-08-17 |
| K082063 | 2008-10-15 |
| K031922 | 2003-10-01 |
| K990975 | 2000-03-15 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Merit Medical Systems, Inc. | UDI-DI | 2024-03-14 | Class II | Employee error | Their is a potential that sheaths labeled with.018 dilators may contain a.038 dilator. | 18 units |
| Merit Medical Systems, Inc. | UDI-DI | 2024-03-14 | Class II | Employee error | Their is a potential that sheaths labeled with.018 dilators may contain a.038 dilator. | 27 units |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. 5 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-02-13 | Class I | Process control | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future | 368,264 | |
| 2025-01-27 | Class II | Packaging process control | Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay. | 40 | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 55305 | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 900 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 4027 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 30 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 745 kits | |
| 2024-05-22 | Class II | Device Design | Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the | 52,410 (updated 06/14/2024) | |
| 2023-03-21 | Class II | Unknown/Undetermined by firm | Custom sheath Introducer contains incorrect needle size | 1186 units | |
| 2021-07-21 | Class II | Process control | There is a potential that a package sheath contains an incorrect dilator. | 373 UNITS | 2023-03-13 |
| 2021-06-30 | Class II | Packaging process control | There is a potential that 7F sheaths are packaged as 10F sheaths. | 760 units | 2023-02-24 |
| 2021-06-30 | Class II | Packaging process control | There is a potential that 7F sheaths are packaged as 10F sheaths. | 760 UNITS | 2023-02-24 |
| 2019-09-12 | Class II | Process control | labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may resul | 15 kits | 2022-05-27 |
| 2017-12-14 | Class II | Under Investigation by firm | Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub. | 60,945 devices | 2020-07-10 |
| 2017-02-16 | Class I | Process control | Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use. | 1,265 total | 2017-08-08 |
| 2016-12-01 | Class II | Process change control | Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire. | 335 | 2017-04-18 |
| 2011-10-07 | Not classified | Nonconforming Material/Component | Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube. | 33,134 | 2012-08-29 |
| 2010-12-17 | Not classified | Component change control | Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response. | 378 units | 2011-07-11 |
| 2010-12-16 | Not classified | Packaging process control | Compromised sterility/weak or open seals. | 28,679 for all products | 2012-08-08 |
| 2010-12-16 | Not classified | Packaging process control | Compromised sterility/weak or open seals. | 28,679 for all products | 2012-08-08 |
| 2010-02-01 | Not classified | Component design/selection | Radiopaque tip may fracture | 13,973 units | 2011-01-05 |
| 2009-12-17 | Not classified | Component design/selection | Radiopaque sheath tip may fracture | 60,982 units | 2010-11-01 |
| 2009-10-21 | Not classified | Component design/selection | Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces. | 17,236 units | 2010-11-08 |
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 4 Sheaths | 2009-12-15 |
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 1 Short Sheath | 2009-12-15 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 1480 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 1039 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 6 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 294 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 1425 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 607 | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 569 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 188 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 68 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 9 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 5781 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 283 units | 2010-02-09 |
| 2009-04-14 | Not classified | Process control | External tubing may separate during use, allowing blood loss. | 1072 units | 2010-02-09 |
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.