Merit MAK™
Merit MAK™: 49 catalogue numbers listed by Merit Medical Systems, Inc., United States, under Dilator, Vessel, For Percutaneous Catheterization. 1 manufacturer in China is registered for this product code.
1manufacturer
49catalogue numbers in this listing
10510(k) clearances naming this product code
6recalls 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 | Merit Medical Systems, 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2025-06-20 |
| Record revised | 2025-05-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 15, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T | Needle Gauge (G)-21G | In distribution |
| 00884450012840 | Introducer Length (cm)-10 cm (4″) | In distribution |
| 00884450008768 | Needle Gauge (G)-21G | In distribution |
| T | Needle Gauge (G)-21G | In distribution |
| T | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450012574 | Introducer Length (cm)-10 cm (4″) | In distribution |
| 00884450094747 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450144411 | Needle Gauge (G)-21G | In distribution |
| 00884450035580 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450008744 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450012680 | Introducer Length (cm)-15 cm (6″) | In distribution |
| 00884450013267 | Introducer Length (cm)-10 cm (4″) | In distribution |
| 00884450012727 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| A | Introducer French Size (F)-5F | In distribution |
| 00884450094785 | Needle Gauge (G)-21G | In distribution |
| 00884450012673 | Introducer French Size (F)-5F | In distribution |
| 00884450012550 | Needle Gauge (G)-21G | In distribution |
| 00884450144398 | Needle Gauge (G)-21G | In distribution |
| 00884450094723 | Introducer French Size (F)-5F | In distribution |
| 00884450154892 | Introducer French Size (F)-4F | In distribution |
| 00884450012604 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450008751 | Needle Gauge (G)-21G | In distribution |
| C | Needle Gauge (G)-21G | In distribution |
| 00884450012857 | Needle Gauge (G)-21G | In distribution |
| 00884450008782 | Introducer Length (cm)-10 cm (4″) | In distribution |
| D | Introducer Length (cm)-10 cm (4″) | In distribution |
| 00884450028520 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450094716 | Introducer French Size (F)-4F | In distribution |
| T | Introducer French Size (F)-5F | In distribution |
| 00884450022047 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450155028 | Needle Gauge (G)-21G | In distribution |
| 00884450012697 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450008812 | Introducer French Size (F)-4F | In distribution |
| 00884450094730 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450094792 | Needle Gauge (G)-21G | In distribution |
| 00884450094754 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450012703 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450012581 | Introducer French Size (F)-5F | In distribution |
| 00884450012567 | Needle Gauge (G)-21G | In distribution |
| 00884450012833 | Introducer French Size (F)-5F | In distribution |
| C | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450144404 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450094761 | Introducer French Size (F)-5F | In distribution |
| 00884450012598 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450011454 | Needle Gauge (G)-21G | In distribution |
| 00884450452288 | Introducer Length (cm)-10 cm (4″) | In distribution |
| 00884450012710 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | In distribution |
| 00884450022030 | Needle Gauge (G)-21G | In distribution |
| 00884450144428 | Guide Wire Diameter (OD)-0.018″ (0.46 mm) | 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 |
| 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 |
|---|---|
| K261310 | 2026-07-27 |
| K242229 | 2025-01-15 |
| K232609 | 2023-09-27 |
| K190175 | 2019-04-10 |
| K130791 | 2013-06-07 |
| K091584 | 2009-10-09 |
| K073035 | 2007-11-20 |
| K070159 | 2007-06-21 |
| K050962 | 2005-05-06 |
| K031691 | 2003-09-03 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-08-12 | Class II | Labeling mix-ups | 7F sheath introducers labeled as 7.5F | 1892 | |
| 2015-06-04 | Class II | Packaging process control | Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038. | 1,445 | 2015-10-26 |
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 5 Sheath Introducers | 2009-12-15 |
| 2004-07-20 | Not classified | Other | Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt. | 634 kits | 2005-01-21 |
| 2004-07-20 | Not classified | Other | Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt. | 1924 kits | 2005-01-21 |
| 2004-07-20 | Not classified | Other | Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt. | 1164 kits | 2005-01-21 |
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.