Mini Stick MAX
Mini Stick MAX Coaxial Microintroducer Kit
1manufacturer
28catalogue numbers in this listing
16recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifetech Scientific (Shenzhen) Co,.ltd | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K132713 |
| Record published | 2024-10-18 |
| Record revised | 2025-02-06 (version 3) |
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 | Box of 10 |
| Sizes | Catheter gauge 4 to 5 Fr; outer diameter 1.42 to 1.73 mm; length 10 cm; lumen/inner diameter 0.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H965457490 | Catheter Gauge 4 Fr | In distribution |
| H965457710 | Catheter Gauge 4 Fr | In distribution |
| H965457480 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457510 | Length 10 cm | In distribution |
| H965457500 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457750 | Outer Diameter 1.73 mm | In distribution |
| H965457810 | Catheter Gauge 4 Fr | In distribution |
| H965457790 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457850 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457680 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457600 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457580 | Outer Diameter 1.42 mm | In distribution |
| H965457720 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457740 | Catheter Gauge 5 Fr | In distribution |
| H965457560 | Length 10 cm | In distribution |
| H965457860 | Catheter Gauge 5 Fr | In distribution |
| H965457550 | Outer Diameter 1.73 mm | In distribution |
| H965457840 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457820 | Length 10 cm | In distribution |
| H965457570 | Outer Diameter 1.42 mm | In distribution |
| H965457590 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457530 | Outer Diameter 1.42 mm | In distribution |
| H965457700 | Outer Diameter 1.42 mm | In distribution |
| H965457760 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457540 | Outer Diameter 1.73 mm | In distribution |
| H965457520 | Lumen/Inner Diameter 0.5 mm | In distribution |
| H965457610 | Outer Diameter 1.42 mm | In distribution |
| H965457830 | Outer Diameter 1.73 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prelude® | Merit Medical Systems, Inc. | 323 |
| Prelude PRO™ | Merit Medical Systems, Inc. | 132 |
| Cook | Cook Incorporated | 125 |
| Avanti | Cordis Corp. | 81 |
| Dilator, Vessel, For Percutaneous Catheterization | B. Braun Interventional Systems, Inc. | 59 |
| Merit MAK™ | Merit Medical Systems, Inc. | 49 |
| Prelude ACT™ | Merit Medical Systems, Inc. | 38 |
| AngioDynamics | Navilyst Medical, Inc. | 38 |
| Super Sheath | Togo Medikit Co., Ltd. | 31 |
| Avanti | Cordis US Corp. | 29 |
| OneStic Micro-Access Introducer | Argon Medical Devices, Inc. | 27 |
| Medcomp Vessel Dilatormedcomp Vessel Dilator | Medical Components Inc | 26 |
Showing 12 of 159. All products under Dilator, Vessel, For Percutaneous Catheterization
Recalls Naming This Product
15 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 104 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 4366 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 959 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 58 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 1676 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 5176 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 15 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 5840 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 600 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 130 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 200 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 155 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 65 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 40 units |
| AngioDynamics, Inc. | 510(k) number | 2024-01-30 | Class II | Process control | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath | 39 units |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-03-18 | Not classified | Other | Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr. | 43 units | 2005-10-25 |
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.