Medcomp Vessel Dilatormedcomp Vessel Dilator
8F (1.0MM ID, 2.7MM OD)8F (1.0MM Vessel Dilatorvessel Dilator (15CM/0.038")(15CM/0.038")
1manufacturer
26catalogue 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 | Medical Components 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, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-10-24 |
| Record revised | 2019-08-02 (version 2) |
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 |
| Packaging | Box of 10 |
| Distribution end date | 2019-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MCD77 | In distribution | |
| MCD74 | In distribution | |
| MCD75 | In distribution | |
| MCD714 | In distribution | |
| MCD716 | In distribution | |
| MCD715 | In distribution | |
| MCD79 | In distribution | |
| MCD78 | In distribution | |
| MCD73 | In distribution | |
| MCD70 | In distribution | |
| MCD76 | In distribution | |
| MCD71 | In distribution | |
| MCD72 | In distribution | |
| MC78 | Withdrawn | |
| MC71 | Withdrawn | |
| MC73 | Withdrawn | |
| MC74 | Withdrawn | |
| MC77 | Withdrawn | |
| MC715 | Withdrawn | |
| MC714 | Withdrawn | |
| MC716 | Withdrawn | |
| MC72 | Withdrawn | |
| MC76 | Withdrawn | |
| MC79 | Withdrawn | |
| MC75 | Withdrawn | |
| MC70 | Withdrawn |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 |
|---|---|
| K800462 | 1980-03-19 |
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.