10fore™
Catalogue number Initial Release, listed by Merit Medical Systems, Inc., United States, under Angiography/Angioplasty Kit. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
20recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | OEQ |
| Device type | Angiography/Angioplasty Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-02-22 |
| Record revised | 2025-05-12 (version 2) |
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 |
| Packaging | Pack of 25, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Initial Release | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 20,409 |
| Merit Medical® | Merit Medical Systems, Inc. | 3,927 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2,085 |
| ACS | American Contract Systems, Inc. | 428 |
| DeRoyal | Deroyal Industries, Inc. | 283 |
| Aligned Medical Solutions | Aligned Medical Solutions | 120 |
| Regard™ | ROi CPS LLC | 57 |
| Stradis Healthcare | Stradis Healthcare | 33 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 23 |
| Namic | Medline Industries, Inc. | 21 |
| basixCOMPAK™ | Merit Medical Systems, Inc. | 8 |
| Stradis | Stradis Healthcare | 7 |
Showing 12 of 49. All products under Angiography/Angioplasty Kit
Recalls
20 of these are Class II. Class II means a temporary or reversible health consequence. 7 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-04-02 | Class II | Nonconforming Material/Component | catheter may experience resistance when being advanced over the guidewire | ||
| 2026-04-02 | Class II | Nonconforming Material/Component | catheter may experience resistance when being advanced over the guidewire | ||
| 2026-04-02 | Class II | Nonconforming Material/Component | catheter may experience resistance when being advanced over the guidewire | ||
| 2025-12-04 | Class II | Process control | Inflation device handle may detach from the syringe during procedure. | 328000 units | |
| 2025-12-04 | Class II | Process control | Inflation device handle may detach from the syringe during procedure. | ||
| 2025-12-04 | Class II | Process control | Inflation device handle may detach from the syringe during procedure. | 173,645 units | |
| 2024-08-19 | Class II | Packaging process control | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. | 7,099 | |
| 2024-08-12 | Class II | Labeling mix-ups | 7F sheath introducers labeled as 7.5F | 24 | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 1,753,625 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 3,647 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 11837 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 103369 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 13,560 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 34197 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 5700 kits | |
| 2020-11-10 | Class II | Packaging process control | Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treat | 90 kits | 2022-10-05 |
| 2020-11-10 | Class II | Packaging process control | Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treat | 80 kits | 2022-10-05 |
| 2020-11-10 | Class II | Packaging process control | Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treat | 42 kits | 2022-10-05 |
| 2018-10-26 | Class II | Error in labeling | Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free) | 88 Kits | 2020-06-12 |
| 2018-07-09 | Class II | Nonconforming Material/Component | A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer. | 6 units | 2020-04-14 |
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.