AngioDynamics
Mini Stick MAX Coaxial Microintroducer Kit
1manufacturer
38catalogue numbers in this listing
2510(k) clearances naming this product 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 | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| 510(k) | K132713 |
| Record published | 2016-09-20 |
| Record revised | 2024-10-21 (version 7) |
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; lumen/inner diameter 0.5 mm; outer diameter 1.42 to 1.73 mm; length 10 cm; needle gauge 21 G |
| Distribution end date | 2024-10-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45773 | Length 10 cm | In distribution |
| 45767 | Needle Gauge 21 G | In distribution |
| 45762 | Needle Gauge 21 G | In distribution |
| 45777 | Needle Gauge 21 G | In distribution |
| 45766 | Length 10 cm | In distribution |
| 45763 | Outer Diameter 1.42 mm | In distribution |
| 45778 | Needle Gauge 21 G | In distribution |
| 45765 | Lumen/Inner Diameter 0.5 mm | In distribution |
| 45769 | Lumen/Inner Diameter 0.5 mm | In distribution |
| 45764 | Outer Diameter 1.73 mm | In distribution |
| 45750 | Catheter Gauge 4 Fr | Withdrawn |
| 45776 | Outer Diameter 1.73 mm | Withdrawn |
| 45761 | Outer Diameter 1.42 mm | Withdrawn |
| 45775 | Length 10 cm | Withdrawn |
| 45759 | Catheter Gauge 4 Fr | Withdrawn |
| 45748 | Catheter Gauge 4 Fr | Withdrawn |
| 45786 | Outer Diameter 1.73 mm | Withdrawn |
| 45751 | Outer Diameter 1.42 mm | Withdrawn |
| 45760 | Outer Diameter 1.42 mm | Withdrawn |
| 45755 | Catheter Gauge 5 Fr | Withdrawn |
| 45774 | Outer Diameter 1.73 mm | Withdrawn |
| 45782 | Length 10 cm | Withdrawn |
| 45754 | Lumen/Inner Diameter 0.5 mm | Withdrawn |
| 45753 | Catheter Gauge 4 Fr | Withdrawn |
| 45756 | Outer Diameter 1.42 mm | Withdrawn |
| 45752 | Outer Diameter 1.42 mm | Withdrawn |
| 45771 | Outer Diameter 1.42 mm | Withdrawn |
| 45757 | Lumen/Inner Diameter 0.5 mm | Withdrawn |
| 45779 | Catheter Gauge 4 Fr | Withdrawn |
| 45772 | Outer Diameter 1.73 mm | Withdrawn |
| 45758 | Outer Diameter 1.42 mm | Withdrawn |
| 45781 | Outer Diameter 1.42 mm | Withdrawn |
| 45783 | Lumen/Inner Diameter 0.5 mm | Withdrawn |
| 45749 | Outer Diameter 1.42 mm | Withdrawn |
| 45784 | Outer Diameter 1.73 mm | Withdrawn |
| 45768 | Outer Diameter 1.42 mm | Withdrawn |
| 45770 | Length 10 cm | Withdrawn |
| 45785 | Length 10 cm | Withdrawn |
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 |
| Super Sheath | Togo Medikit Co., Ltd. | 31 |
| Avanti | Cordis US Corp. | 29 |
| Mini Stick MAX | AngioDynamics, Inc. | 28 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132713 | 2013-09-27 |
| K123445 | 2013-04-01 |
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 |
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.