Who else makes this device?

Name: Truwave X 3 (3 CC)/Vamp Plus (215 CM)
Brand: Truwave X 3 (3 CC)/Vamp Plus (215 CM)

Cardiovascular › DiagnosticCatheter, Continuous Flush

Truwave X 3 (3 CC)/Vamp Plus (215 CM)

Catalogue number T100671M, listed by Edwards Lifesciences Technology Sarl, United States, under Catheter, Continuous Flush. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

4recalls on this code

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KRA
Manufacturer	City	Province	Registered as	Device types
Shanghai Wallaby Medical Technologies Co., Inc.	Shanghai	Shanghai	Contract manufacturer	5
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Suzhou Zenith Vascular Scitech Limited	Suzhou	Jiangsu	Manufacturer	6
Suzhou Hengrui Hongyuan Medical Co., Ltd.	Suzhou	Jiangsu	Manufacturer	3
Vascupatent Medical (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Manufacturer	1

Record

Regulatory record for Truwave X 3 (3 CC)/Vamp Plus (215 CM)
Listed by	Edwards Lifesciences Technology Sarl, United States
FDA product code	KRA
Device type	Catheter, Continuous Flush
Device class	Class 2
Regulation	21 CFR 870.1210
Establishment	Contract manufacturer, Specification developer, Manufacturer
510(k)	K181684
Record published	2020-04-24

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: STORE IN A COOL, DRY PLACE
Packaging	Shipper of 10

Catalogue Numbers

Catalogue numbers for Truwave X 3 (3 CC)/Vamp Plus (215 CM)
Catalogue number	Size	Status
T100671M	Volume 3 cc, length 215 cm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Fountain®	Merit Medical Systems, Inc.	154
PulseSpray	AngioDynamics, Inc.	149
Merit Maestro®	Merit Medical Systems, Inc.	143
Phenom™ Catheter	Cathera, Inc.	103
UniFuse	AngioDynamics, Inc.	84
CXI	Cook Incorporated	48
Uni-Fuse+	AngioDynamics, Inc.	32
Prowler	Medos International Sàrl	27
Truwave, Vamp	Edwards Lifesciences Technology Sarl	26
ICU Medical	ICU Medical, Inc	21
Cantata	Cook Incorporated	20
Truwave, Vamp Plus	Edwards Lifesciences Technology Sarl	19

Showing 12 of 149. All products under Catheter, Continuous Flush

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K181684	2018-11-08
K180275	2018-10-24
K173586	2018-04-05
K161962	2016-11-28

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Truwave X 3 (3 CC)/Vamp Plus (215 CM)
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Edwards Lifesciences Technology Sarl	UDI-DI	2023-10-04	Class II	Device Design	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.	168,014 units

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
2013-01-30	Class II	Process change control	The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.	30,467	2016-03-10
2009-02-09	Not classified	Software design	Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: “Fault. CCO Catheter Verification. Use Bolus Mode”.	2,728 units	2011-04-11
2009-02-09	Not classified	Software design	Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: “Fault. CCO Catheter Verification. Use Bolus Mode”.	107 units	2011-04-11
2009-02-09	Not classified	Software design	Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: “Fault. CCO Catheter Verification. Use Bolus Mode”.	35 units	2011-04-11

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.