Who else makes this device?

Name: Arterial Wand
Brand: Arterial Wand

Arterial Wand · Introducer, Catheter → Cardiovascular

13manufacturers in China registered for this device type

1catalogue number

13510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DYB
Manufacturer	City	Province	Registered as	Device types
Mehow Innovative (Huizhou) Ltd.	Huizhou	Guangdong	Contract manufacturer	11
Tianjin Demax Medical Technology Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	5
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Shanghai INT Medical Instruments Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	10
Lepu Medical Technology (Beijing) Co., Ltd.	Beijing	Beijing	Manufacturer	7
Beijing Target Medical Technologies Inc.	Beijing	Beijing	Contract manufacturer	7
Beijing Demax Medical Technology Co., Ltd.	Beijing	Beijing	Manufacturer	5
Curatia Medical Limited	Suzhou	Jiangsu	Specification developer	5
Tianjin Ethylene Oxide Sterilization Technology Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	4
Shanghai Microport EP Medtech Co., Ltd.	Shanghai	Shanghai	Manufacturer	3
Becton Dickinson Medical Devices Co., Ltd. Suzhou	Suzhou	Jiangsu	Contract manufacturer	2
Cardiocycle Medical(Suzhou) Co., Ltd.	Suzhou	Jiangsu	Complaint-file establishment	1

Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter

Record

Regulatory record for Arterial Wand
Listed by	Access Scientific, Inc., United States
FDA product code	DYB
Device type	Introducer, Catheter
Device class	Class 2
Regulation	21 CFR 870.1340
510(k)	K181563
Record published	2018-10-11

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Pack of 12, pack of 10
Sizes	Needle gauge 21 G; catheter gauge 3 Fr; catheter length 5 cm

Catalogue Numbers

Catalogue numbers for Arterial Wand
Catalogue number	Size	Status
3Fr x 5cm	Needle Gauge 21 G	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Demax	Beijing Demax Medical Technology Co., Ltd.	2,841
Arrow	Teleflex Medical LLC	1,036
Prelude IDeal™	Merit Medical Systems, Inc.	294
Fast-Cath™	St. Jude Medical	213
Flexor	Cook Incorporated	182
Prelude Ease™	Merit Medical Systems, Inc.	176
Performer	Cook Incorporated	174
VSI	Teleflex Medical LLC	154
Peel-Away	Cook Incorporated	153
OptiSeal™	Greatbatch Medical	127
Brilliant	Lepu Medical Technology (Beijing) Co., Ltd.	122
Super Sheath	Togo Medikit Co., Ltd.	122

Showing 12 of 439. All products under Introducer, Catheter

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K183066	2019-07-25
K182243	2018-09-18
K162322	2016-11-17
K131148	2013-09-04
K131300	2013-06-07
K121748	2012-07-27
K111417	2011-07-15
K111138	2011-06-22
K101422	2011-03-22
K101150	2010-08-13
K093022	2010-01-20
K090372	2009-03-30
K081697	2008-12-04

Recalls

1 of these is 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.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2013-08-16	Class II	Labeling Change Control	Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.	160 units	2013-09-24

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.

Arterial Wand