Who else makes this device?

Name: ClariVein® IC
Brand: ClariVein® IC

Cardiovascular › DiagnosticCatheter, Continuous Flush

ClariVein® IC

ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion wire connected to a proximally located integral battery motor drive unit (MDU). The MDU includes…

Registry build 21.09.26

ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion wire connected to a proximally located integral battery motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features to facilitate physician-controlled infusion of the selected agent. The ClariVein® IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly’s infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The ClariVein® IC has no user serviceable parts or capital equipment. It is fully disposable. DEMO UNIT.

5manufacturers in China registered for this device type

4catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

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 ClariVein® IC
Listed by	Vascular Insights, LLC, United States
FDA product code	KRA
Device type	Catheter, Continuous Flush
Device class	Class 2
Regulation	21 CFR 870.1210
Record published	2016-09-19
Record revised	2022-06-10 (version 8)

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
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Store in cool, dry place
Packaging	Case of 5, case of 6
Sizes	Length 45 to 85 cm; outer diameter 0.0345 in
Distribution end date	2020-11-03

Catalogue Numbers

Catalogue numbers for ClariVein® IC
Catalogue number	Size	Status
85-018-E140S	Length 85 cm	Withdrawn
45-018-E2S	Outer Diameter 0.0345 in	Withdrawn
65-018-E4S	Length 65 cm	Withdrawn
DEMO-45-018-E2S	Length 45 cm	Withdrawn

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
K153502	2016-01-06
K071468	2008-03-20

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
2017-11-09	Class II	Process control	Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.	928	2018-12-18

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.