Who else makes this device?

Name: Rebar
Brand: Rebar

Rebar · Catheter, Continuous Flush → Cardiovascular

5manufacturers in China registered for this device type

14catalogue numbers in this listing

17510(k) clearances naming this product 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 Rebar
Listed by	Micro Therapeutics, Inc., United States
FDA product code	KRA
Device type	Catheter, Continuous Flush
Device class	Class 2
Regulation	21 CFR 870.1210
510(k)	K093750
Record published	2015-10-09
Record revised	2026-06-12 (version 10)

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
Storage	Storage environment temperature 50 to 90 °F; Special storage condition: Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Sizes	Length 130 to 153 cm
Distribution end date	2026-06-09

Catalogue Numbers

Catalogue numbers for Rebar
Catalogue number	Size	Status
105-5080-153C	Length 153 cm	In distribution
105-5083-153		In distribution
105-5081-130		In distribution
105-5082-130	Length 130 cm	In distribution
105-5081-153		In distribution
105-5082-145	Length 145 cm	In distribution
105-5082-145		In distribution
105-5078-153	Length 153 cm	In distribution
105-5081-153		In distribution
105-5081-130		In distribution
105-5081-153	Length 153 cm	In distribution
105-5083-153	Length 153 cm	In distribution
105-5082-130		Withdrawn
105-5080-153	Length 153 cm	Withdrawn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
K113289	2012-08-01
K090870	2009-05-01
K051990	2006-01-04
K042187	2004-09-02
K034036	2004-02-13
K031992	2003-08-07
K030688	2003-03-28
K024122	2003-03-07
K024118	2003-02-03
K010004	2001-02-13
K002723	2000-09-28
K001966	2000-07-20
K993672	2000-01-04
K974473	1998-06-17
K980104	1998-04-10
K964868	1997-05-20
K954020	1996-01-02

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 Rebar
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Covidien	510(k) number	2022-06-30	Class II	Under Investigation by firm	Outer carton packaging of microcatheters were exposed to wet substance during transport.	8 units
Covidien	510(k) number	2022-06-30	Class II	Under Investigation by firm	Outer carton packaging of microcatheters were exposed to wet substance during transport.	2 units

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.

Rebar