Royal Flush
Royal Flush Plus High-Flow Catheter delivers contrast media and therapeutic agents during angiographic procedures. Its intended vessels include the peripheral, carotid and coronary…
Royal Flush Plus High-Flow Catheter delivers contrast media and therapeutic agents during angiographic procedures. Its intended vessels include the peripheral, carotid and coronary circulation, with neurovascular use excluded. The catheter has a single-lumen shaft connected to a Luer lock adapter.
The range is supplied in 5.0 and 6.0 Fr sizes and lengths from 25 to 110 cm. Devices are supplied sterile for single use. Configurations can include a pigtail tip, which is kept curled when the labeled length is measured.
Listed Item
Royal Flush, Plus High-Flow Catheter
Length Reference
For a catheter labeled 110 cm or longer, length is measured from the proximal end of the strain relief to the distal catheter end. For the shorter sizes, the measurement starts at the distal end of the strain relief. This makes the reference point dependent on labeled length.
11manufacturers in China registered for this device type
70catalogue numbers in this listing
15510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180054 |
| Record published | 2016-09-24 |
| Record revised | 2020-10-16 (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 dark, dry, cool place. |
| Packaging | Pack of 5, each of 5 |
| Distribution end date | 2017-09-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G30051 | In distribution | |
| G19583 | In distribution | |
| G08768 | In distribution | |
| G13470 | In distribution | |
| G58547 | In distribution | |
| G58550 | In distribution | |
| G12698 | In distribution | |
| G27985 | In distribution | |
| G27576 | In distribution | |
| G04902 | In distribution | |
| G58542 | In distribution | |
| G10429 | In distribution | |
| G05062 | In distribution | |
| G27973 | In distribution | |
| G12634 | In distribution | |
| G58548 | In distribution | |
| G12137 | In distribution | |
| G58554 | In distribution | |
| G05770 | In distribution | |
| G04848 | In distribution | |
| G05093 | In distribution | |
| G05398 | In distribution | |
| G27508 | In distribution | |
| G06769 | In distribution | |
| G05060 | In distribution | |
| G04721 | In distribution | |
| G58552 | In distribution | |
| G58543 | In distribution | |
| G05188 | In distribution | |
| G13510 | In distribution | |
| G04872 | In distribution | |
| G27982 | In distribution | |
| G10539 | In distribution | |
| G04835 | In distribution | |
| G11392 | In distribution | |
| G05607 | In distribution | |
| G58545 | In distribution | |
| G58553 | In distribution | |
| G58556 | In distribution | |
| G04909 | In distribution | |
| G13771 | In distribution | |
| G58551 | In distribution | |
| G05001 | In distribution | |
| G58544 | In distribution | |
| G12569 | In distribution | |
| G27986 | In distribution | |
| G04704 | In distribution | |
| G27569 | In distribution | |
| G11342 | In distribution | |
| G10430 | In distribution | |
| G05423 | In distribution | |
| G05424 | In distribution | |
| G12568 | In distribution | |
| G06157 | In distribution | |
| G27583 | In distribution | |
| G04827 | In distribution | |
| G58549 | In distribution | |
| G06535 | In distribution | |
| G05061 | In distribution | |
| G58555 | In distribution | |
| G12138 | In distribution | |
| G05115 | In distribution | |
| G58546 | In distribution | |
| G04967 | In distribution | |
| G05380 | In distribution | |
| G31101 | In distribution | |
| G13656 | In distribution | |
| G04894 | In distribution | |
| G09637 | In distribution | |
| G04146 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performa® | Merit Medical Systems, Inc. | 1,101 |
| Impress® | Merit Medical Systems, Inc. | 839 |
| Super Torque | Cordis Corp. | 611 |
| Soft-Vu | AngioDynamics, Inc. | 591 |
| Torcon NB | Cook Incorporated | 463 |
| Mariner | AngioDynamics, Inc. | 323 |
| INT,SlideCath | Shanghai Kindly Medical Instruments Co., Ltd. | 264 |
| Infiniti | Cordis Corp. | 251 |
| Infiniti | Cordis US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181722 | 2019-03-22 |
| K180846 | 2018-12-19 |
| K180792 | 2018-11-30 |
| K180286 | 2018-10-26 |
| K180054 | 2018-10-05 |
| K172635 | 2018-04-03 |
| K171264 | 2018-01-25 |
| K173289 | 2017-11-15 |
| K162448 | 2017-05-26 |
| K161822 | 2016-10-27 |
| K133130 | 2015-01-09 |
| K122937 | 2012-12-14 |
| K002254 | 2001-03-16 |
| K974774 | 1998-10-16 |
| K882796 | 1988-07-28 |
Recalls
4 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. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-04-02 | Class I | Under Investigation by firm | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, d | 271 | |
| 2026-04-02 | Class I | Under Investigation by firm | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, d | 11,253 | |
| 2026-04-02 | Class I | Under Investigation by firm | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, d | 4,245 | |
| 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 20 units | |
| 2025-05-15 | Class I | Process change control | Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. | 26986 units | |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 5 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 35 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 265 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 10 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 30 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 30 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 5 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 145 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 100 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 90 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 10 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 20 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 35 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 25 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 10 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 1,679 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 33 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 98 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 35 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 5 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 10 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 5 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 195 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 5 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 250 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 30 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 60 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 232 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 5 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 165 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 311 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 951 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 5 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 20 | 2020-06-30 |
| 2019-10-21 | Class II | Process change control | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | 25 | 2020-06-30 |
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.