Tearaway Introducer Set
96 catalogue numbers from INT-046-00, listed by Galt Medical Corp., United States, under Introducer, Catheter. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
96catalogue numbers in this listing
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.
| 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
| 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 | 2019-05-23 |
| Record revised | 2024-03-20 (version 6) |
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 of 10, shipper box of 100, shipper box of 25, shelf box of 5, shipper box of 40, shelf box |
| Sizes | Catheter gauge 2 to 16 Fr |
| Distribution end date | 2021-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INT-046-00 | Catheter Gauge 5.5 Fr | In distribution |
| INT-101-14 | Catheter Gauge 2 Fr | In distribution |
| INT-106-00 | Catheter Gauge 3 Fr | In distribution |
| INT-107-40 | Catheter Gauge 4 Fr | In distribution |
| HMP-105-07 | Catheter Gauge 7 Fr | In distribution |
| INT-105-07 | Catheter Gauge 7 Fr | In distribution |
| HMP-105-08 | Catheter Gauge 8 Fr | In distribution |
| INT-106-18 | Catheter Gauge 8 Fr | In distribution |
| INT-107-30 | Catheter Gauge 3 Fr | In distribution |
| INT-106-01 | Catheter Gauge 3.5 Fr | In distribution |
| INT-106-10 | Catheter Gauge 3 Fr | In distribution |
| INT-128-16 | Catheter Gauge 4 Fr | In distribution |
| INT-105-25 | Catheter Gauge 7 Fr | In distribution |
| INT-105-49 | Catheter Gauge 14 Fr | In distribution |
| INT-106-33 | Catheter Gauge 5 Fr | In distribution |
| INT-101-15 | Catheter Gauge 2 Fr | In distribution |
| INT-105-21 | Catheter Gauge 5 Fr | In distribution |
| INT-106-04 | Catheter Gauge 5 Fr | In distribution |
| INT-106-20 | Catheter Gauge 6.5 Fr | In distribution |
| INT-107-51 | Catheter Gauge 5 Fr | In distribution |
| INT-105-13 | Catheter Gauge 11 Fr | In distribution |
| INT-107-41 | Catheter Gauge 4 Fr | In distribution |
| INT-105-11 | Catheter Gauge 10 Fr | In distribution |
| INT-101-02 | Catheter Gauge 2 Fr | In distribution |
| INT-105-08 | Catheter Gauge 8 Fr | In distribution |
| INT-116-16 | Catheter Gauge 16 Fr | In distribution |
| INT-105-58 | Catheter Gauge 6 Fr | In distribution |
| INT-105-47 | Catheter Gauge 13 Fr | In distribution |
| INT-105-41 | Catheter Gauge 11 Fr | In distribution |
| INT-105-17 | Catheter Gauge 14 Fr | In distribution |
| INT-105-33 | Catheter Gauge 9 Fr | In distribution |
| INT-105-35 | Catheter Gauge 9 Fr | In distribution |
| INT-105-09 | Catheter Gauge 9 Fr | In distribution |
| INT-105-18 | Catheter Gauge 15 Fr | In distribution |
| INT-106-12 | Catheter Gauge 4 Fr | In distribution |
| INT-107-70 | Catheter Gauge 7 Fr | In distribution |
| INT-128-03 | Catheter Gauge 4 Fr | In distribution |
| INT-105-53 | Catheter Gauge 16 Fr | In distribution |
| INT-106-02 | Catheter Gauge 4 Fr | In distribution |
| INT-105-37 | Catheter Gauge 10 Fr | In distribution |
| INT-107-60 | Catheter Gauge 6 Fr | In distribution |
| INT-105-06 | Catheter Gauge 6 Fr | In distribution |
| INT-106-03 | Catheter Gauge 4.5 Fr | In distribution |
| INT-106-05 | Catheter Gauge 5.5 Fr | In distribution |
| INT-106-31 | Catheter Gauge 5 Fr | In distribution |
| INT-106-13 | Catheter Gauge 4.5 Fr | In distribution |
| INT-105-02 | Catheter Gauge 4 Fr | In distribution |
| INT-105-34 | Catheter Gauge 9 Fr | In distribution |
| INT-115-14 | Catheter Gauge 4 Fr | In distribution |
| INT-128-15 | Catheter Gauge 4 Fr | In distribution |
| INT-128-17 | Catheter Gauge 4 Fr | In distribution |
| INT-107-65 | Catheter Gauge 6.5 Fr | In distribution |
| INT-105-19 | Catheter Gauge 16 Fr | In distribution |
| INT-101-03 | Catheter Gauge 3 Fr | In distribution |
| INT-114-00 | Catheter Gauge 16 Fr | In distribution |
| INT-105-39 | Catheter Gauge 10 Fr | In distribution |
| INT-107-50 | Catheter Gauge 5 Fr | In distribution |
| INT-106-09 | Catheter Gauge 6 Fr | In distribution |
| INT-106-14 | Catheter Gauge 5 Fr | In distribution |
| INT-105-29 | Catheter Gauge 8 Fr | In distribution |
| INT-105-04 | Catheter Gauge 5 Fr | In distribution |
| INT-106-11 | Catheter Gauge 3.5 Fr | In distribution |
| INT-105-45 | Catheter Gauge 12 Fr | In distribution |
| INT-128-01 | Catheter Gauge 4 Fr | In distribution |
| INT-128-04 | Catheter Gauge 4 Fr | In distribution |
| INT-106-37 | Catheter Gauge 7 Fr | In distribution |
| INT-106-06 | Catheter Gauge 6 Fr | In distribution |
| INT-106-07 | Catheter Gauge 7 Fr | In distribution |
| INT-106-15 | Catheter Gauge 5.5 Fr | In distribution |
| INT-106-17 | Catheter Gauge 7 Fr | In distribution |
| INT-106-16 | Catheter Gauge 6 Fr | In distribution |
| INT-105-57 | Catheter Gauge 6 Fr | In distribution |
| INT-105-12 | Catheter Gauge 10.5 Fr | In distribution |
| INT-105-16 | Catheter Gauge 13 Fr | In distribution |
| INT-105-14 | Catheter Gauge 12 Fr | In distribution |
| INT-128-02 | Catheter Gauge 4 Fr | In distribution |
| INT-107-80 | Catheter Gauge 8 Fr | Withdrawn |
| INT-105-64 | Catheter Gauge 15 Fr | Withdrawn |
| INT-105-42 | Catheter Gauge 11 Fr | Withdrawn |
| INT-105-51 | Catheter Gauge 14 Fr | Withdrawn |
| INT-105-55 | Catheter Gauge 16 Fr | Withdrawn |
| INT-105-46 | Catheter Gauge 12 Fr | Withdrawn |
| INT-107-35 | Catheter Gauge 3.5 Fr | Withdrawn |
| INT-105-61 | Catheter Gauge 13 Fr | Withdrawn |
| INT-105-30 | Catheter Gauge 8 Fr | Withdrawn |
| INT-106-32 | Catheter Gauge 6.5 Fr | Withdrawn |
| INT-107-90 | Catheter Gauge 9 Fr | Withdrawn |
| INT-109-11 | Catheter Gauge 11 Fr | Withdrawn |
| INT-105-15 | Catheter Gauge 12.5 Fr | Withdrawn |
| INT-105-60 | Catheter Gauge 12 Fr | Withdrawn |
| INT-107-45 | Catheter Gauge 4.5 Fr | Withdrawn |
| INT-105-10 | Catheter Gauge 9.5 Fr | Withdrawn |
| INT-107-55 | Catheter Gauge 5.5 Fr | Withdrawn |
| INT-115-15 | Catheter Gauge 5 Fr | Withdrawn |
| INT-109-12 | Catheter Gauge 12 Fr | Withdrawn |
| INT-105-50 | Catheter Gauge 14 Fr | Withdrawn |
Same 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
| 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Galt Medical Corp. | UDI-DI | 2025-03-27 | Class II | Process control | Due to a potential open seal in the sterile barrier packaging. | 490 units |
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.
| 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.