Who else makes this device?

Name: Tearaway Indroducer Set
Brand: Tearaway Indroducer Set

Tearaway Indroducer Set · Introducer, Catheter → Cardiovascular

13manufacturers in China registered for this device type

1catalogue number

6510(k) clearances naming this product code

9recalls on this code

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 Tearaway Indroducer Set
Listed by	Galt Medical Corp., United States
FDA product code	DYB
Device type	Introducer, Catheter
Device class	Class 2
Regulation	21 CFR 870.1340
Establishment	Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2017-01-19
Record revised	2024-03-20 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, serial number
Packaging	Shelf box, shipper box of 10
Sizes	Catheter gauge 14 Fr
Distribution end date	2020-12-14

Catalogue Numbers

Catalogue numbers for Tearaway Indroducer Set
Catalogue number	Size	Status
INT-109-14	Catheter Gauge 14 Fr	Withdrawn

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
K173287	2017-12-21
K153533	2016-07-05
K140028	2014-08-21
K123430	2013-04-12
K112398	2012-04-12
K043525	2005-02-09

Recalls

9 of these are 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
2025-03-27	Class II	Process control	Due to a potential open seal in the sterile barrier packaging.	100 systems
2023-05-08	Class II	Process design	Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use	490
2023-05-08	Class II	Process design	Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use	6036
2018-05-02	Class II	Other	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever	9050	2020-07-20
2018-05-02	Class II	Other	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever	3160	2020-07-20
2018-05-02	Class II	Other	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever	23777	2020-07-20
2018-05-02	Class II	Other	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever	10950	2020-07-20
2014-07-25	Class II	Nonconforming Material/Component	The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.	11,155 units in total	2016-02-26
2014-07-25	Class II	Nonconforming Material/Component	The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.	11,155 units in total	2016-02-26

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.

Tearaway Indroducer Set