Superdimension™
Catalogue number 00884450258507, listed by Merit Medical Systems, Inc., United States, under Catheter, Intravascular, Diagnostic. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code
33recalls 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 | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-01-04 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5, pack of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450258507 | Internal Diameter-0.046″ (1.17 mm) | In distribution |
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 |
|---|---|
| K233268 | 2024-05-22 |
| K191608 | 2019-07-16 |
| K110643 | 2011-07-01 |
| K093004 | 2010-02-12 |
| K053171 | 2006-01-19 |
| K000659 | 2000-03-29 |
| K914208 | 1991-12-18 |
| K913682 | 1991-11-15 |
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 |
|---|---|---|---|---|---|
| 2013-09-13 | Class II | Process control | 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape. | 200 | 2014-01-03 |
| 2013-05-02 | Class II | Process control | Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape. | 1,465 | 2013-07-22 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 92 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 265 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 3,636 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 1,057 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 124 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 679 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 57 units | 2012-03-23 |
| 2010-10-25 | Not classified | Process control | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve’s fixed luer may be over- or under-tightened, causing leaking at the bond joint. | 1033 units | 2012-03-23 |
| 2010-05-05 | Not classified | Process control | Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands. | 96 units | 2010-06-01 |
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 1 connection tube | 2009-12-15 |
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 1 connection tube | 2009-12-15 |
| 2008-09-12 | Not classified | Process control | Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748. | 399 kits | 2009-01-13 |
| 2008-04-15 | Not classified | Process control | Convenience kits may be non-sterile due to inadequate package sealing. | 10 kits | 2008-09-03 |
| 2008-04-15 | Not classified | Process control | Convenience kits may be non-sterile due to inadequate package sealing. | 10 kits | 2008-09-03 |
| 2008-04-15 | Not classified | Process control | Convenience kits may be non-sterile due to inadequate package sealing. | 119 kits | 2008-09-03 |
| 2005-09-02 | Not classified | Other | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | 99 units | 2005-10-28 |
| 2005-09-02 | Not classified | Other | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | 84 units | 2005-10-28 |
| 2005-09-02 | Not classified | Other | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | 243 units | 2005-10-28 |
| 2005-09-02 | Not classified | Other | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | 372 units | 2005-10-28 |
| 2005-09-02 | Not classified | Other | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | 119 units | 2005-10-28 |
| 2004-10-15 | Not classified | Other | Merit Custom Convenience Kits contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.These needles may detach from their hub during use. | 10202 kits | 2004-12-15 |
| 2004-09-14 | Not classified | Other | Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch. | 143 kits | 2005-03-31 |
| 2003-11-05 | Not classified | Other | Angiographic catheter tips may separate during use. | 32 units | 2003-12-01 |
| 2003-11-05 | Not classified | Other | Angiographic catheter tips may separate during use. | 410 units | 2003-12-01 |
| 2003-10-01 | Not classified | Other | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated t | 6155 units | 2004-02-02 |
| 2003-10-01 | Not classified | Other | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated t | 30 units | 2004-02-02 |
| 2003-10-01 | Not classified | Other | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated t | 1927 units | 2004-02-02 |
| 2003-05-16 | Not classified | Other | Cracks in the syringe barrels could allow for air aspiration into the syringe barrel. | 20 kits | 2003-07-21 |
| 2003-02-13 | Not classified | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. | 100 kits. | 2003-03-07 |
| 2003-02-13 | Not classified | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. | 250 kits | 2003-03-07 |
| 2003-02-13 | Not classified | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. | 82 kits. | 2003-03-07 |
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.