pNOVUS 21 Microcatheter

The pNOVUS 21 Microcatheter is intended for delivering diagnostic agents (such as contrast media), therapeutic agents (such as antiplatelet or vasodilating drugs) and non-liquid…

Registry build 21.09.26

The pNOVUS 21 Microcatheter is intended for delivering diagnostic agents (such as contrast media), therapeutic agents (such as antiplatelet or vasodilating drugs) and non-liquid interventional devices (such as thrombectomy devices) to intra- and extracranial brain-supplying arteries and intra- and extracranial brain-draining veins. pNOVUS 21 is generally inserted either through a sheath or guide-catheter. Arterial access is typically gained in the femoral, brachial, or radial artery but other access sites (e.g. carotid artery) may be used in rare occasions. Most common sites for venous access are the femoral, brachial, basilic or cephalic vein, but other accessible veins may be used depending on the condition to be treated.

11manufacturers in China registered for this device type
1catalogue number
2510(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.

Chinese manufacturers registered for FDA product code DQO
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

Regulatory record for pNOVUS 21 Microcatheter
Listed by Phenox Limited, Ireland
FDA product code DQO
Device type Catheter, Intravascular, Diagnostic
Device class Class 2
Regulation 21 CFR 870.1200
Establishment Complaint-file establishment, Manufacturer
Record published 2023-01-09

Specifications

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

Catalogue Numbers

Catalogue numbers for pNOVUS 21 Microcatheter
Catalogue number Size Status
PNOV-21-160 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K242420 2024-11-12
K221279 2022-11-28

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer