Avanti
Avanti+ F5 PED. 55MM.021 Inches -R
1manufacturer
81catalogue numbers in this listing
1510(k) clearance
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 Corp., United States |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| 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 |
| Supplied as a kit | Yes |
| 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, box, case of 5 |
| Distribution end date | 2024-08-08 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 504608X | In distribution | ||
| 504614Z | In distribution | ||
| 504504S | In distribution | ||
| 504508X | In distribution | ||
| 504607D | In distribution | ||
| 504617Z | In distribution | ||
| 504606P | In distribution | ||
| 504656A | In distribution | ||
| 504609A | In distribution | ||
| 504607V | In distribution | ||
| 504608V | In distribution | ||
| 504616Z | In distribution | ||
| 504506X | In distribution | ||
| 504615Z | In distribution | ||
| 504407X | In distribution | ||
| 402605T | In distribution | ||
| 504656T | In distribution | ||
| 402605P | In distribution | ||
| 402606R | In distribution | ||
| 402608X | In distribution | ||
| 402606T | In distribution | ||
| 402607X | In distribution | ||
| 504404X | In distribution | ||
| 504658X | In distribution | ||
| 504611T | In distribution | ||
| 504656X | In distribution | ||
| 504607T | In distribution | ||
| 402604P | In distribution | ||
| 504624Z | In distribution | ||
| 402656X | In distribution | ||
| 402605A | In distribution | ||
| 402604A | In distribution | ||
| 402655X | In distribution | ||
| 504625Z | In distribution | ||
| 504608A | In distribution | ||
| 402606P | In distribution | ||
| 504657X | In distribution | ||
| 504626Z | In distribution | ||
| 402608A | In distribution | ||
| 504605T | In distribution | ||
| 402606A | In distribution | ||
| 504505X | In distribution | ||
| 504505S | In distribution | ||
| 504606S | In distribution | ||
| 504608T | In distribution | ||
| 504507X | In distribution | ||
| 402604X | In distribution | ||
| 504604T | In distribution | ||
| 504606D | In distribution | ||
| 504610T | In distribution | ||
| 504608D | In distribution | ||
| 402608T | In distribution | ||
| 402609T | In distribution | ||
| 402605X | In distribution | ||
| 402606X | In distribution | ||
| 504606X | In distribution | ||
| 504655X | In distribution | ||
| 504606T | In distribution | ||
| SRA0166 | 5 | Withdrawn | |
| SR9015 | Withdrawn | ||
| 504609D | Withdrawn | ||
| 504655T | Withdrawn | ||
| 504409X | Withdrawn | ||
| 402604R | Withdrawn | ||
| 504506S | Withdrawn | ||
| SRA0027 | Withdrawn | ||
| 402604T | Withdrawn | ||
| 504658T | Withdrawn | ||
| 402611T | Withdrawn | ||
| 504609T | Withdrawn | ||
| 402605R | Withdrawn | ||
| SR9010 | Withdrawn | ||
| 504658A | Withdrawn | ||
| 504655A | Withdrawn | ||
| 504657T | Withdrawn | ||
| 402610T | Withdrawn | ||
| 402607T | Withdrawn | ||
| SR9019 | Withdrawn | ||
| SRA0002 | Withdrawn | ||
| SR9017 | Withdrawn | ||
| 504611A | 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 |
| 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 |
| 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 |
|---|---|
| K970392 | 1997-04-24 |
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.