Peel-Away
Curved Multipurpose Peel-Away Introducer Set - Without Wire Guide
13manufacturers in China registered for this device type
153catalogue numbers in this listing
21510(k) clearances naming this product code
40recalls 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 | Cook Incorporated, United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-05-01 (version 6) |
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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Distribution end date | 2024-04-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G11575 | In distribution | |
| G06575 | In distribution | |
| G04116 | In distribution | |
| G04934 | In distribution | |
| G04611 | In distribution | |
| G02201 | In distribution | |
| G04703 | In distribution | |
| G11555 | In distribution | |
| G07373 | In distribution | |
| G06551 | In distribution | |
| G06576 | In distribution | |
| G08799 | In distribution | |
| G11508 | In distribution | |
| G04896 | In distribution | |
| G06566 | In distribution | |
| G06571 | In distribution | |
| G11552 | In distribution | |
| G03080 | In distribution | |
| G29219 | In distribution | |
| G02066 | In distribution | |
| G27237 | In distribution | |
| G06570 | In distribution | |
| G08631 | In distribution | |
| G11570 | In distribution | |
| G08484 | In distribution | |
| G07008 | In distribution | |
| G04117 | In distribution | |
| G01979 | In distribution | |
| G08579 | In distribution | |
| G06765 | In distribution | |
| G02547 | In distribution | |
| G09124 | In distribution | |
| G04362 | In distribution | |
| G10067 | In distribution | |
| G01900 | In distribution | |
| G06549 | In distribution | |
| G06531 | In distribution | |
| G02086 | In distribution | |
| G08096 | In distribution | |
| G05513 | In distribution | |
| G06645 | In distribution | |
| G07109 | In distribution | |
| G07190 | In distribution | |
| G02916 | In distribution | |
| G07436 | In distribution | |
| G02196 | In distribution | |
| G04272 | In distribution | |
| G04377 | In distribution | |
| G01951 | In distribution | |
| G04961 | In distribution | |
| G31029 | In distribution | |
| G06554 | In distribution | |
| G06553 | In distribution | |
| G08034 | In distribution | |
| G05762 | In distribution | |
| G11563 | In distribution | |
| G11551 | In distribution | |
| G02195 | In distribution | |
| G11550 | In distribution | |
| G08410 | In distribution | |
| G05143 | In distribution | |
| G29216 | In distribution | |
| G06630 | In distribution | |
| G02480 | In distribution | |
| G06567 | In distribution | |
| G00915 | In distribution | |
| G02348 | In distribution | |
| G02325 | In distribution | |
| G08814 | In distribution | |
| G07334 | In distribution | |
| G06573 | In distribution | |
| G06456 | In distribution | |
| G06548 | In distribution | |
| G28253 | In distribution | |
| G05764 | In distribution | |
| G01933 | In distribution | |
| G04606 | In distribution | |
| G06580 | In distribution | |
| G07108 | In distribution | |
| G06547 | In distribution | |
| G09288 | In distribution | |
| G08037 | In distribution | |
| G01964 | In distribution | |
| G07275 | In distribution | |
| G01965 | In distribution | |
| G02993 | In distribution | |
| G06577 | In distribution | |
| G02171 | In distribution | |
| G10328 | In distribution | |
| G04306 | In distribution | |
| G07234 | In distribution | |
| G11559 | In distribution | |
| G05144 | In distribution | |
| G03246 | In distribution | |
| G08630 | In distribution | |
| G08487 | In distribution | |
| G05791 | In distribution | |
| G08568 | In distribution | |
| G01934 | In distribution | |
| G29208 | In distribution | |
| G07119 | In distribution | |
| G06579 | In distribution | |
| G08490 | In distribution | |
| G07140 | In distribution | |
| G06560 | In distribution | |
| G04559 | In distribution | |
| G06773 | In distribution | |
| G28262 | In distribution | |
| G06574 | In distribution | |
| G02151 | In distribution | |
| G02635 | In distribution | |
| G06562 | In distribution | |
| G04645 | In distribution | |
| G02103 | Withdrawn | |
| G12961 | Withdrawn | |
| G06569 | Withdrawn | |
| G04492 | Withdrawn | |
| G01921 | Withdrawn | |
| G06621 | Withdrawn | |
| G02106 | Withdrawn | |
| G29690 | Withdrawn | |
| G10069 | Withdrawn | |
| G29207 | Withdrawn | |
| G06790 | Withdrawn | |
| G02187 | Withdrawn | |
| G02265 | Withdrawn | |
| G06729 | Withdrawn | |
| G07871 | Withdrawn | |
| G07040 | Withdrawn | |
| G06563 | Withdrawn | |
| G07038 | Withdrawn | |
| G06612 | Withdrawn | |
| G09196 | Withdrawn | |
| G29838 | Withdrawn | |
| G04386 | Withdrawn | |
| G06620 | Withdrawn | |
| G06578 | Withdrawn | |
| G29839 | Withdrawn | |
| G29840 | Withdrawn | |
| G06396 | Withdrawn | |
| G29855 | Withdrawn | |
| G29264 | Withdrawn | |
| G04696 | Withdrawn | |
| G12943 | Withdrawn | |
| G10329 | Withdrawn | |
| G05767 | Withdrawn | |
| G06748 | Withdrawn | |
| G30242 | Withdrawn | |
| G07042 | Withdrawn | |
| G04642 | Withdrawn | |
| G09702 | Withdrawn | |
| G28195 | Withdrawn | |
| G05219 | 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 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
| Tearaway Introducer Set | Galt Medical Corp. | 96 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240589 | 2024-03-25 |
| K203670 | 2021-02-16 |
| K171609 | 2018-06-04 |
| K172980 | 2018-05-03 |
| K171988 | 2018-03-30 |
| K171820 | 2018-03-09 |
| K171275 | 2017-12-20 |
| K173685 | 2017-12-20 |
| K173068 | 2017-11-17 |
| K170020 | 2017-09-28 |
| K171853 | 2017-08-24 |
| K171999 | 2017-07-31 |
| K153430 | 2016-03-07 |
| K152044 | 2015-08-14 |
| K142829 | 2015-07-28 |
| K142819 | 2015-07-24 |
| K132592 | 2014-10-09 |
| K133114 | 2014-07-03 |
| K123235 | 2013-02-14 |
| K001985 | 2001-01-25 |
| K895044 | 1990-02-26 |
Recalls
21 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2025-11-26 | Class II | Process control | Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly. | 7952 units | |
| 2025-11-26 | Class II | Process control | Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly. | 23 units | |
| 2025-11-26 | Class II | Process control | Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly. | 15 units | |
| 2025-04-17 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. | 99 units | |
| 2025-04-17 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. | 89 units | |
| 2024-09-16 | Class II | Process control | Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect. | 50 units | |
| 2024-03-01 | Class II | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 55 units | |
| 2021-11-12 | Class II | Process control | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa | 50 units | 2024-04-26 |
| 2021-11-12 | Class II | Process control | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa | 47 units | 2024-04-26 |
| 2021-09-28 | Class II | Employee error | Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed | 48 (US) | 2024-02-28 |
| 2021-09-28 | Class II | Employee error | Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed | 48 (OUS) | 2024-02-28 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 1262 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 2807 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 4767 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 1152 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 1527 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 9310 (2 additional as of 1/14/21) | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 611 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 902 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 458 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 383 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 1024 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 3797 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 4408 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 228 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 8362 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 9768 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 2605 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 1967 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 228 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 1780 | 2022-09-07 |
| 2020-11-24 | Class I | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but a | 631 | 2022-09-07 |
| 2018-12-21 | Class II | Under Investigation by firm | The products were manufactured with longer than specified sheaths. | 24 | 2020-04-30 |
| 2017-02-01 | Class II | Under Investigation by firm | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients | 778 | 2018-09-28 |
| 2017-02-01 | Class II | Under Investigation by firm | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients | 29 | 2018-09-28 |
| 2017-02-01 | Class II | Under Investigation by firm | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients | 854 | 2018-09-28 |
| 2017-02-01 | Class II | Under Investigation by firm | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients | 41,975 | 2018-09-28 |
| 2017-02-01 | Class II | Under Investigation by firm | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients | 884 | 2018-09-28 |
| 2016-04-15 | Class II | Unknown/Undetermined by firm | Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications | 12,595 | 2017-08-04 |
| 2016-01-20 | Class II | Under Investigation by firm | Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. | 25 | 2016-11-21 |
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.