Merit Maestro®
143 catalogue numbers from 00884450290866, listed by Merit Medical Systems, Inc., United States, under Catheter, Continuous Flush. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
143catalogue numbers in this listing
7510(k) clearances naming this product code
27recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-10-16 |
| Record revised | 2021-10-11 (version 5) |
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 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450290866 | Catheter Length-150 cm (59″) | In distribution |
| 00884450013984 | Catheter Tip Shape-45° | In distribution |
| 00884450038390 | Catheter Length-150 cm (59″) | In distribution |
| A | Distal French Size (F)-2.1F | In distribution |
| 00884450290743 | Distal French Size (F)-2.4F | In distribution |
| 00884450358139 | Catheter Tip Shape-Straight | In distribution |
| 00884450013878 | Distal French Size (F)-2.4F | In distribution |
| G | Catheter Length-110 cm (43″) | In distribution |
| 00884450742754 | Distal French Size (F)-2.1F | In distribution |
| 00884450013847 | Distal French Size (F)-2.4F | In distribution |
| A | Catheter Length-175 cm (69″) | In distribution |
| G | Catheter Tip Shape-Straight | In distribution |
| 00884450358009 | Catheter Length-110 cm (43″) | In distribution |
| 00884450290859 | Distal French Size (F)-2.8F | In distribution |
| 00884450038437 | Catheter Length-110 cm (43″) | In distribution |
| G | Catheter Length-150 cm (59″) | In distribution |
| 00884450358108 | Distal French Size (F)-2.9F | In distribution |
| 00884450307854 | Catheter Tip Shape-Swan Neck | In distribution |
| 00884450013908 | Distal French Size (F)-2.4F | In distribution |
| 00884450357958 | Distal French Size (F)-2.4F | In distribution |
| 00884450290835 | Distal French Size (F)-2.8F | In distribution |
| 00884450038420 | Distal French Size (F)-2.9F | In distribution |
| 00884450307991 | Catheter Length-150 cm (59″) | In distribution |
| 00884450335284 | Catheter Length-150 cm (59″) | In distribution |
| 00884450013861 | Distal French Size (F)-2.4F | In distribution |
| 00884450290736 | Distal French Size (F)-2.4F | In distribution |
| 00884450038413 | Catheter Length-110 cm (43″) | In distribution |
| 00884450357934 | Catheter Length-130 cm (51″) | In distribution |
| 00884450357927 | Catheter Length-110 cm (43″) | In distribution |
| A | Catheter Length-165 cm (65″) | In distribution |
| 00884450290934 | Catheter Tip Shape-Straight | In distribution |
| 00884450290927 | Catheter Length-130 cm (51″) | In distribution |
| G | Catheter Length-110 cm (43″) | In distribution |
| 00884450335222 | Catheter Tip Shape-Swan Neck | In distribution |
| G | Distal French Size (F)-2.8F | In distribution |
| G | Catheter Tip Shape-45° | In distribution |
| 00884450357989 | Distal French Size (F)-2.4F | In distribution |
| G | Catheter Length-150 cm (59″) | In distribution |
| A | Catheter Length-175 cm (69″) | In distribution |
| G | Distal French Size (F)-2.9F | In distribution |
| G | Catheter Tip Shape-45° | In distribution |
| G | Catheter Length-110 cm (43″) | In distribution |
| G | Catheter Tip Shape-45° | In distribution |
| 00884450038444 | Catheter Tip Shape-45° | In distribution |
| 00884450290903 | Catheter Tip Shape-Straight | In distribution |
| 00884450013915 | Distal French Size (F)-2.4F | In distribution |
| 00884450290804 | Catheter Length-110 cm (43″) | In distribution |
| 00884450335260 | Catheter Tip Shape-Straight | In distribution |
| 00884450358146 | Catheter Tip Shape-45° | In distribution |
| 00884450038451 | Distal French Size (F)-2.9F | In distribution |
| 00884450358092 | Distal French Size (F)-2.9F | In distribution |
| G | Distal French Size (F)-2.8F | In distribution |
| 00884450290958 | Distal French Size (F)-2.9F | In distribution |
| 00884450357910 | Catheter Tip Shape-Swan Neck | In distribution |
| 00884450290965 | Distal French Size (F)-2.9F | In distribution |
| 00884450013960 | Catheter Tip Shape-45° | In distribution |
| 00884450742952 | Distal French Size (F)-2.8F | In distribution |
| G | Catheter Tip Shape-Straight | In distribution |
| G | Catheter Tip Shape-Swan Neck | In distribution |
| A | Distal French Size (F)-2.9F | In distribution |
| G | Catheter Tip Shape-Swan Neck | In distribution |
| 00884450290767 | Catheter Length-150 cm (59″) | In distribution |
| 00884450358115 | Catheter Tip Shape-45° | In distribution |
| 00884450307861 | Distal French Size (F)-2.1F | In distribution |
| 00884450290842 | Catheter Length-130 cm (51″) | In distribution |
| G | Catheter Tip Shape-Straight | In distribution |
| 00884450335291 | Catheter Length-150 cm (59″) | In distribution |
| 00884450013977 | Catheter Tip Shape-45° | In distribution |
| 00884450307793 | Distal French Size (F)-2.1F | In distribution |
| 00884450290781 | Catheter Tip Shape-Straight | In distribution |
| A | Distal French Size (F)-2.4F | In distribution |
| G | Distal French Size (F)-2.9F | In distribution |
| 00884450290897 | Catheter Tip Shape-Swan Neck | In distribution |
| 00884450290712 | Catheter Tip Shape-Swan Neck | In distribution |
| G | Catheter Tip Shape-45° | In distribution |
| 00884450357972 | Distal French Size (F)-2.4F | In distribution |
| G | Catheter Length-130 cm (51″) | In distribution |
| 00884450357965 | Catheter Tip Shape-45° | In distribution |
| 00884450335246 | Distal French Size (F)-2.1F | In distribution |
| 00884450358436 | Distal French Size (F)-2.4F | In distribution |
| 00884450335215 | Catheter Tip Shape-45° | In distribution |
| 00884450290873 | Distal French Size (F)-2.8F | In distribution |
| 00884450743034 | Catheter Tip Shape-Straight | In distribution |
| 00884450013953 | Catheter Tip Shape-Straight | In distribution |
| G | Catheter Tip Shape-Straight | In distribution |
| G | Distal French Size (F)-2.8F | In distribution |
| 00884450013939 | Distal French Size (F)-2.8F | In distribution |
| 00884450013991 | Catheter Length-110 cm (43″) | In distribution |
| 00884450357996 | Catheter Tip Shape-45° | In distribution |
| 00884450290941 | Catheter Tip Shape-45° | In distribution |
| A | Distal French Size (F)-2.8F | In distribution |
| 00884450358160 | Catheter Tip Shape-Straight | In distribution |
| G | Distal French Size (F)-2.8F | In distribution |
| 00884450290880 | Catheter Length-110 cm (43″) | In distribution |
| 00884450358153 | Catheter Tip Shape-Swan Neck | In distribution |
| G | Distal French Size (F)-2.1F | In distribution |
| 00884450014004 | Distal French Size (F)-2.8F | In distribution |
| A | Catheter Length-165 cm (65″) | In distribution |
| 00884450013946 | Distal French Size (F)-2.8F | In distribution |
| 00884450358023 | Distal French Size (F)-2.8F | In distribution |
| 00884450307809 | Catheter Length-110 cm (43″) | In distribution |
| 00884450290774 | Catheter Length-150 cm (59″) | In distribution |
| 00884450290705 | Catheter Length-110 cm (43″) | In distribution |
| 00884450290729 | Distal French Size (F)-2.4F | In distribution |
| 00884450358061 | Catheter Tip Shape-Swan Neck | In distribution |
| A | Catheter Tip Shape-Swan Neck | In distribution |
| 00884450335277 | Catheter Length-150 cm (59″) | In distribution |
| 00884450290828 | Distal French Size (F)-2.8F | In distribution |
| A | Distal French Size (F)-2.1F | In distribution |
| G | Catheter Tip Shape-45°; Catheter Length-150 cm (59″); Distal French Size (F)-2.4F; Catheter Tip Shape-45° | In distribution |
| G | Distal French Size (F)-2.4F | In distribution |
| 00884450358085 | Catheter Tip Shape-45° | In distribution |
| G | Catheter Tip Shape-Swan Neck | In distribution |
| 00884450290798 | Distal French Size (F)-2.8F | In distribution |
| 00884450357903 | Catheter Length-110 cm (43″) | In distribution |
| 00884450290910 | Distal French Size (F)-2.9F | In distribution |
| 00884450013892 | Catheter Length-150 cm (59″) | In distribution |
| 00884450335253 | Distal French Size (F)-2.1F | In distribution |
| 00884450038468 | Catheter Tip Shape-Straight | In distribution |
| 00884450307892 | Distal French Size (F)-2.1F | In distribution |
| 00884450014011 | Distal French Size (F)-2.8F | In distribution |
| 00884450038406 | Catheter Tip Shape-Swan Neck | In distribution |
| A | Catheter Tip Shape-Straight | In distribution |
| A | Distal French Size (F)-2.1F | In distribution |
| 00884450358078 | Catheter Length-150 cm (59″) | In distribution |
| 00884450358122 | Catheter Tip Shape-Swan Neck | In distribution |
| 00884450358443 | Distal French Size (F)-2.8F | In distribution |
| 00884450013922 | Distal French Size (F)-2.4F | In distribution |
| 00884450307816 | Catheter Tip Shape-Swan Neck | In distribution |
| 00884450013885 | Catheter Tip Shape-45° | In distribution |
| 00884450358030 | Catheter Length-130 cm (51″) | In distribution |
| G | Catheter Tip Shape-45° | In distribution |
| 00884450038383 | Catheter Length-150 cm (59″) | In distribution |
| 00884450335239 | Distal French Size (F)-2.1F | In distribution |
| 00884450290750 | Distal French Size (F)-2.4F | In distribution |
| A | Catheter Length-165 cm (65″) | In distribution |
| 00884450308004 | Distal French Size (F)-2.1F | In distribution |
| 00884450013854 | Catheter Length-130 cm (51″) | In distribution |
| G | Catheter Tip Shape-Straight | In distribution |
| 00884450358047 | Distal French Size (F)-2.8F | In distribution |
| A | Distal French Size (F)-2.8F | In distribution |
| 00884450358016 | Catheter Length-110 cm (43″) | In distribution |
| G | Catheter Length-130 cm (51″) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| UniFuse | AngioDynamics, Inc. | 84 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| ICU Medical | ICU Medical, Inc | 21 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
| Deltran | Utah Medical Products, Inc. | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211525 | 2021-07-16 |
| K193082 | 2020-08-07 |
| K201907 | 2020-08-06 |
| K172081 | 2017-08-04 |
| K161921 | 2016-11-04 |
| K082613 | 2008-12-30 |
| K962129 | 1997-04-15 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Merit Medical Systems, Inc. | UDI-DI | 2023-11-06 | Class II | Package design/selection | The sterility of microcatheter and infusion system devices cannot be guaranteed. | 717 units |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2014-09-26 | Class II | Mixed-up of materials/components | These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F. | 56 units | 2014-11-19 |
| 2013-12-06 | Class II | Packaging process control | Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end p | 59 | 2014-01-27 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 40 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 19 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 5 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 240 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 44 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 42 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 18 uinits | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 240 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 10 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 5 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 5 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 149 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 59 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 370 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 5 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 11 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 5 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 29 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 7 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 31 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 4 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 26 units | 2010-09-13 |
| 2010-01-06 | Not classified | Storage | Infusion catheters may become brittle and break during use. | 25 units | 2010-09-13 |
| 2008-05-14 | Not classified | Packaging process control | Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential ris | 15 units | 2010-03-08 |
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.