Vaxcel
Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 4.5F x 10cm Dilator, NiTi Guidewire, and Radiopaque Tip
1manufacturer
14catalogue 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) | K974640 |
| Record published | 2015-09-15 |
| 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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
| Sizes | Catheter gauge 4 to 6 Fr; length 9.4 to 10 cm; outer diameter 1.3 to 2 mm; needle gauge 21 G; lumen/inner diameter 0.5 mm |
| Distribution end date | 2024-10-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45986 | Outer Diameter 1.5 mm | In distribution |
| 45988 | Catheter Gauge 4 Fr | In distribution |
| 45981 | Length 9.4 cm | In distribution |
| 45982 | Length 9.4 cm | In distribution |
| 45994 | Outer Diameter 1.7 mm | In distribution |
| 45980 | Length 9.4 cm | In distribution |
| 45992 | Catheter Gauge 4 Fr | In distribution |
| 45991 | Catheter Gauge 6 Fr | Withdrawn |
| 45985 | Length 10 cm | Withdrawn |
| 45984 | Outer Diameter 1.8 mm | Withdrawn |
| 45989 | Length 10 cm | Withdrawn |
| 45993 | Outer Diameter 1.7 mm | Withdrawn |
| 45987 | Length 9.4 cm | Withdrawn |
| 45990 | Length 10 cm | Withdrawn |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 |
| 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 |
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
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | 510(k) number | 2004-03-05 | Not classified | Other | Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr. | 75 units (box/10) | 2005-10-26 |
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.