Namic
MTO Arterial EXT. SET 6.625 PED- OEM PG
11manufacturers in China registered for this device type
107catalogue numbers in this listing
3510(k) clearances naming this product 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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Record published | 2021-07-26 |
| Record revised | 2026-02-26 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 25, box of 500, case of 25, case of 50, box of 10, case of 500 |
| Sizes | Length 4.5 to 72 in; pressure 200 to 1200 psi |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70015320 | Length 20 in | In distribution | |
| 81011102 | FALSE | 100 | In distribution |
| 91031203 | Length 20 in | In distribution | |
| 91051602 | Length 60 in | In distribution | |
| 90703062 | Length 6 in | In distribution | |
| 81051202 | FALSE | 100 | In distribution |
| 91021202 | Length 20 in | In distribution | |
| 88001603 | FALSE | 50 | In distribution |
| 91051722 | Length 72 in | In distribution | |
| 80703050 | FALSE | 100 | In distribution |
| 81011482 | FALSE | 100 | In distribution |
| 81021102 | FALSE | 100 | In distribution |
| 80703122 | FALSE | 100 | In distribution |
| 91011302 | Length 30 in | In distribution | |
| 91001483 | Pressure 1000 psi | In distribution | |
| 91031482 | Length 48 in | In distribution | |
| 80515111 | FALSE | 100 | In distribution |
| 91001203 | Pressure 1000 psi | In distribution | |
| 81021302 | FALSE | 100 | In distribution |
| 91051203 | Length 20 in | In distribution | |
| 91051303 | Length 30 in | In distribution | |
| 91031483 | Length 48 in | In distribution | |
| 80515251 | FALSE | 100 | In distribution |
| 81051203 | FALSE | 100 | In distribution |
| 92031102 | Pressure 1200 psi | In distribution | |
| 70015312 | Pressure 200 psi | In distribution | |
| 81021202 | FALSE | 100 | In distribution |
| 92051482 | Pressure 1200 psi | In distribution | |
| 92051103 | Pressure 1200 psi | In distribution | |
| 81051102 | FALSE | 100 | In distribution |
| 91001103 | Length 10 in | In distribution | |
| 91500028 | In distribution | ||
| 92051602 | Pressure 1200 psi | In distribution | |
| 88001483 | FALSE | 100 | In distribution |
| 70015333 | Pressure 200 psi | In distribution | |
| 81051483 | FALSE | 100 | In distribution |
| 81011202 | FALSE | 100 | In distribution |
| 92031302 | Length 30 in | In distribution | |
| 92031203 | Length 20 in | In distribution | |
| 90703092 | Length 9 in | In distribution | |
| 81051042 | FALSE | 500 | In distribution |
| 92031483 | Pressure 1200 psi | In distribution | |
| 81031303 | FALSE | 100 | In distribution |
| 88001103 | FALSE | 100 | In distribution |
| 92051722 | Length 72 in | In distribution | |
| 88001203 | FALSE | 100 | In distribution |
| 81031302 | FALSE | 100 | In distribution |
| 92051483 | Length 48 in | In distribution | |
| 91031302 | Length 30 in | In distribution | |
| 92051603 | Pressure 1200 psi | In distribution | |
| 91011202 | Pressure 1000 psi | In distribution | |
| 90500040 | In distribution | ||
| 92031103 | Pressure 1200 psi | In distribution | |
| 81031483 | FALSE | 100 | In distribution |
| 91051102 | Pressure 1200 psi | In distribution | |
| 81031202 | FALSE | 100 | In distribution |
| DYNJPMTBG36MF | In distribution | ||
| 91021102 | Pressure 1000 psi | In distribution | |
| 91021302 | Pressure 500 psi | In distribution | |
| 92051202 | Length 20 in | In distribution | |
| 91051202 | Length 20 in | In distribution | |
| 92051723 | Pressure 1200 psi | In distribution | |
| 91051483 | Length 48 in | In distribution | |
| 91031303 | Pressure 1200 psi | In distribution | |
| 70015412 | Length 12 in | In distribution | |
| 92031303 | Pressure 1200 psi | In distribution | |
| 91031202 | Length 20 in | In distribution | |
| 81031482 | FALSE | 100 | In distribution |
| 81051103 | FALSE | 100 | In distribution |
| 91001303 | Length 30 in | In distribution | |
| 91011602 | Length 60 in | In distribution | |
| 90703050 | Length 4.5 in | In distribution | |
| 92051203 | Length 20 in | In distribution | |
| 91011102 | Length 10 in | In distribution | |
| 92031482 | Pressure 1200 psi | In distribution | |
| 91031103 | Length 10 in | In distribution | |
| 70015433 | Length 33 in | In distribution | |
| 88001303 | FALSE | 100 | In distribution |
| 81051302 | FALSE | 100 | In distribution |
| 92051102 | Length 10 in | In distribution | |
| 81031203 | FALSE | 100 | In distribution |
| 92051303 | Pressure 1200 psi | In distribution | |
| 91051723 | Length 72 in | In distribution | |
| 91031102 | Pressure 1200 psi | In distribution | |
| 92031202 | Length 20 in | In distribution | |
| 92051302 | Length 30 in | In distribution | |
| 91051103 | Length 10 in | In distribution | |
| 81011602 | FALSE | 50 | In distribution |
| 81051602 | FALSE | 100 | In distribution |
| 80703062 | FALSE | 100 | In distribution |
| DYNJNVFD72 | In distribution | ||
| 91001603 | Length 60 in | In distribution | |
| 81021482 | FALSE | 100 | In distribution |
| 70015420 | Pressure 200 psi | In distribution | |
| 90703122 | Length 12 in | In distribution | |
| DYNJTBGHP48R | In distribution | ||
| 91051482 | Pressure 1200 psi | In distribution | |
| 81051603 | FALSE | 100 | In distribution |
| 91051302 | Pressure 1200 psi | In distribution | |
| 91021482 | Pressure 500 psi | In distribution | |
| 91051603 | Pressure 1200 psi | In distribution | |
| 81011302 | FALSE | 100 | In distribution |
| 81031102 | FALSE | 100 | In distribution |
| 91011482 | Pressure 1000 psi | In distribution | |
| 81031103 | FALSE | 100 | In distribution |
| 81051482 | FALSE | 100 | In distribution |
| 81051303 | FALSE | 100 | 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 |
|---|---|
| K160660 | 2017-01-19 |
| K120008 | 2012-08-17 |
| K965112 | 1997-10-10 |
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.