Who else makes this device?

Name: Co-SET+
Brand: Co-SET+

Co-SET+ · Computer, Diagnostic, Pre-Programmed, Single-Function → Cardiovascular

5manufacturers in China registered for this device type

1catalogue number

11510(k) clearances naming this product code

3recalls on this code

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DXG
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57
Orantech Inc.	Shenzhen	Guangdong	Contract manufacturer	40
Shenzhen Comen Medical Instruments Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	24

Record

Regulatory record for Co-SET+
Listed by	Edwards Lifesciences Technology Sarl, United States
FDA product code	DXG
Device type	Computer, Diagnostic, Pre-Programmed, Single-Function
Device class	Class 2
Regulation	21 CFR 870.1435
Establishment	Contract manufacturer, Specification developer, Manufacturer
510(k)	K043103
Record published	2016-09-03
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Special storage condition: STORE IN A COOL, DRY PLACE.
Sizes	Length 120 in

Catalogue Numbers

Catalogue numbers for Co-SET+
Catalogue number	Size	Status
9850A	Length 120 in	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
LiDCO Ltd	Lidco Ltd.	133
LiDCO	Lidco Ltd.	32
Transonic	Transonic Systems, Inc.	31
Computer, Diagnostic, Pre-Programmed, Single-Function	Edwards Lifesciences Technology Sarl	23
Retia Medical	Retia Medical, LLC	17
EV1000	Edwards Lifesciences Technology Sarl	11
Computer, Diagnostic, Pre-Programmed, Single-Function	GE Healthcare Finland OY	5
Pediasat	Edwards Lifesciences Technology Sarl	4
LiDCO	Masimo Corporation	4
ICU Medical	ICU Medical, Inc	4
Cnap® Monitor 500 HD	Cnsystems Medizintechnik GmbH	4
Vigileo	Edwards Lifesciences Technology Sarl	3

Showing 12 of 39. All products under Computer, Diagnostic, Pre-Programmed, Single-Function

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K193179	2019-12-17
K131892	2014-05-22
K131588	2014-05-22
K110597	2011-06-14
K103094	2011-05-17
K100709	2010-12-07
K082308	2008-12-09
K062134	2006-08-22
K060660	2006-04-25
K043103	2004-12-09
K040287	2004-04-26

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Co-SET+
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Edwards Lifesciences Technology Sarl	510(k) number	2008-09-12	Not classified	Device Design	Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73 due to the potential of inaccurate	6934 instruments	2012-02-08
Edwards Lifesciences Technology Sarl	510(k) number	2007-05-17	Not classified	Software design	MAP offset errors: If users are “slaving” mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), at times, on some bedside mo	2,680 units in North America distribution	2009-10-09

Recalls

The FDA has not published a severity grade for these. 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
2010-06-25	Not classified	Process design	The recall was initiated because the Edwards’ MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.	20 units	2011-05-24

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.

Co-SET+