Avanti
CSI Avanti+ Cardiology MS.038
1manufacturer
29catalogue numbers in this listing
2recalls 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 | Cordis US Corp., United States |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K970392 |
| Record published | 2016-08-01 |
| Record revised | 2025-12-15 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Box of 5, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 504607X | In distribution | |
| 504604P | In distribution | |
| 504406X | In distribution | |
| 504405X | In distribution | |
| 402607P | In distribution | |
| 504610A | In distribution | |
| 402609X | In distribution | |
| 504657A | In distribution | |
| 402610X | In distribution | |
| 402607R | In distribution | |
| 504604A | In distribution | |
| 402611X | In distribution | |
| 504610X | In distribution | |
| 504605A | In distribution | |
| 504509X | In distribution | |
| 504605X | In distribution | |
| 402610A | In distribution | |
| 504606A | In distribution | |
| 504605P | In distribution | |
| 504604S | In distribution | |
| 504408X | In distribution | |
| 402609A | In distribution | |
| 504605S | In distribution | |
| 504606V | In distribution | |
| 402607A | In distribution | |
| 504604X | In distribution | |
| 504607A | In distribution | |
| 504611X | In distribution | |
| 504609X | 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 |
| 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
Recalls Naming This Product
2 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 | Closed |
|---|---|---|---|---|---|---|---|
| Cordis US Corp. | 510(k) number | 2021-06-09 | Class II | Under Investigation by firm | The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. | 680 units | 2023-02-16 |
| Cordis US Corp. | 510(k) number | 2015-12-31 | Class II | Mixed-up of materials/components | Incorrect cannula of the sheath introducer (smaller than intended). | 1,985 units | 2016-08-25 |
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.