Prelude®
323 catalogue numbers from 10884450008116, 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
323catalogue 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 | 2016-09-20 |
| Record revised | 2024-03-20 (version 7) |
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, manufacturing date |
| Packaging | Pack of 4, pack of 21, pack of 2, case of 4 |
| Sizes | Guidewire diameter 0.025 to 0.035 in; needle gauge 18 to 20 G |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10884450008116 | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| F | Guide Wire Diameter-0.025″ (0.64 mm) | 5 | In distribution |
| F | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| F | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450614065 | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| J | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450614997 | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| 10884450614980 | Sheath French Size (F)-4F | 5 | In distribution |
| 10884450008086 | Needle Gauge (G)-21G | 5 | In distribution |
| F | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450614027 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| 10884450011369 | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450010591 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| F | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450055387 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450008956 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331870 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450331771 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| F | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450009809 | Sheath French Size (F)-7F | 5 | In distribution |
| F | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450331382 | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450007904 | Sheath French Size (F)-4F | 5 | In distribution |
| 10884450614546 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450123734 | 10 | In distribution | |
| 10884450331511 | Sheath French Size (F)-4F | 5 | In distribution |
| 10884450614942 | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450008079 | Sheath French Size (F)-4F | 5 | In distribution |
| D | Needle Gauge (G)-20G | 5 | In distribution |
| 10884450331962 | Sheath French Size (F)-8F | 5 | In distribution |
| F | Sheath French Size (F)-6F | 5 | In distribution |
| F | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450615147 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450331238 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450391508 | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| 10884450331955 | Sheath French Size (F)-8F | 5 | In distribution |
| 10884450035716 | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450331320 | Sheath French Size (F)-5F | 5 | In distribution |
| F | Sheath French Size (F)-7F | 5 | In distribution |
| 10884450614652 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331566 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450330521 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450331641 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450614645 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450010515 | Sheath French Size (F)-8F | 5 | In distribution |
| 10884450331436 | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450330460 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450035709 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| 10884450007829 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450614478 | Sheath French Size (F)-7F | 5 | In distribution |
| 10884450008871 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| F | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450012328 | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450331313 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450009625 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450015121 | 10 | In distribution | |
| 10884450614713 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450614744 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331924 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| F | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450331610 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450614508 | Sheath French Size (F)-7F | 5 | In distribution |
| 10884450030438 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| 10884450614959 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| F | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| F | Sheath French Size (F)-5F | 5 | In distribution |
| J | Sheath French Size (F)-4F | 5 | In distribution |
| F | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450614447 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450332037 | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450025960 | 10 | In distribution | |
| F | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450029388 | 10 | In distribution | |
| 10884450008932 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331757 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450008147 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450614751 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450614522 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331221 | 5 | In distribution | |
| 10884450331214 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450010560 | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| F | Sheath French Size (F)-7F | 5 | In distribution |
| 10884450330613 | Sheath French Size (F)-7F | 5 | In distribution |
| F | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| D | Needle Gauge (G)-21G | 5 | In distribution |
| F | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450331726 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450330668 | Sheath French Size (F)-8F | 5 | In distribution |
| F | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450331351 | 5 | In distribution | |
| 10884450614591 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450331979 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450331269 | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450332044 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450331856 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| F | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| F | Sheath French Size (F)-5F | 5 | In distribution |
| F | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450331672 | Needle Gauge (G)-18G | 5 | In distribution |
| 10884450008918 | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450331573 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450615024 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450614843 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450614492 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450614539 | Sheath French Size (F)-4F | 5 | In distribution |
| 10884450081522 | Needle Gauge (G)-18G | 5 | In distribution |
| 10884450356712 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450292447 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450331337 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450007867 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| F | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450009656 | Sheath French Size (F)-7F | 5 | In distribution |
| F | Sheath French Size (F)-8F | 5 | In distribution |
| F | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450008840 | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450331474 | Sheath French Size (F)-7F | 5 | In distribution |
| D | Needle Gauge (G)-18G | 5 | In distribution |
| F | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450015107 | 10 | In distribution | |
| F | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| F | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| F | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450615079 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450614461 | Sheath French Size (F)-7F | 5 | In distribution |
| 10884450331634 | Sheath French Size (F)-5F | 5 | In distribution |
| F | Sheath French Size (F)-6F | 5 | In distribution |
| F | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| F | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450050726 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450331542 | Sheath French Size (F)-4F | 5 | In distribution |
| F | Sheath French Size (F)-4F | 5 | In distribution |
| 10884450331535 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450123758 | 10 | In distribution | |
| F | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| F | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450123727 | 10 | In distribution | |
| 10884450010621 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450330699 | Sheath French Size (F)-8F | 5 | In distribution |
| 10884450615109 | Needle Gauge (G)-18G | 5 | In distribution |
| 10884450615161 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450615178 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450007836 | Sheath French Size (F)-6F | 5 | In distribution |
| F | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450331825 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450331696 | Needle Gauge (G)-18G | 5 | In distribution |
| 10884450356705 | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450615062 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450014988 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| 10884450614331 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| 10884450331801 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450614812 | Sheath French Size (F)-6F | 5 | In distribution |
| F | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450009663 | Sheath French Size (F)-8F | 5 | In distribution |
| 10884450010584 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450094058 | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| 10884450614515 | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450331429 | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| D | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450330620 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450614782 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331559 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| 10884450008154 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450035679 | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450330576 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331252 | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| F | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331597 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450010577 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450614799 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450008888 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450010652 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450331689 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450614089 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450094065 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| 10884450614690 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331948 | Sheath French Size (F)-8F | 5 | In distribution |
| 10884450614577 | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| 10884450615031 | Guide Wire Diameter-0.025″ (0.64 mm) | 5 | In distribution |
| 10884450035723 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| F | Sheath French Size (F)-8F | 5 | In distribution |
| 10884450009793 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450007843 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450331863 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450615086 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| F | Sheath French Size (F)-7F | 5 | In distribution |
| F | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450615130 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450614928 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450007911 | Sheath French Size (F)-4F | 5 | In distribution |
| 10884450123741 | 10 | In distribution | |
| 10884450331344 | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450331290 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450292430 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450292423 | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| 10884450614676 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450015114 | 10 | In distribution | |
| 10884450008949 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450023768 | 10 | In distribution | |
| 10884450614614 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450008925 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450356729 | Sheath French Size (F)-6F | 5 | In distribution |
| F | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| 10884450615000 | Sheath French Size (F)-4F | 5 | In distribution |
| 10884450331658 | Sheath French Size (F)-5F | 5 | In distribution |
| 10884450614584 | Needle Gauge (G)-18G | 5 | In distribution |
| 10884450009748 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450614157 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| F | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450331207 | Needle Gauge (G)-21G | 5 | In distribution |
| F | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| F | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450614607 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450015046 | Needle Gauge (G)-21G | 5 | In distribution |
| 10884450009724 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450330484 | Sheath French Size (F)-4F | 5 | In distribution |
| 10884450025977 | 10 | In distribution | |
| 10884450008895 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450615116 | Sheath French Size (F)-5F | 5 | In distribution |
| F | Sheath French Size (F)-6F | 5 | In distribution |
| F | Guide Wire Diameter-0.018″ (0.46 mm) | 5 | In distribution |
| F | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331283 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450614553 | Sheath French Size (F)-7F | 5 | In distribution |
| 10884450614768 | Guide Wire Diameter-0.038″ (0.97 mm) | 5 | In distribution |
| F | Sheath French Size (F)-8F | 5 | In distribution |
| 10884450331245 | Sheath French Size (F)-4F | 5 | In distribution |
| F | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| 10884450330644 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331276 | Sheath French Size (F)-4F | 5 | In distribution |
| 10884450331900 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450614911 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450331764 | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450330682 | Sheath French Size (F)-8F | 5 | In distribution |
| F | Sheath French Size (F)-6F | 5 | In distribution |
| F | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450614737 | Sheath French Size (F)-8F | 5 | In distribution |
| 10884450330590 | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450330583 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450614935 | Sheath French Size (F)-4F | 5 | In distribution |
| 10884450024505 | Sheath Length (cm)-7 cm (2.8″) | 5 | In distribution |
| 10884450013769 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450054106 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450332020 | Sheath Length (cm)-11 cm (4.3″) | 5 | In distribution |
| 10884450009717 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450614454 | Needle Gauge (G)-21G | 5 | In distribution |
| G | Sheath French Size (F)-7F | 5 | In distribution |
| F | Sheath French Size (F)-6F | 5 | In distribution |
| 10884450008901 | Sheath Length (cm)-23 cm (9″) | 5 | In distribution |
| 10884450008857 | Guide Wire Diameter-0.035″ (0.89 mm) | 5 | In distribution |
| 10884450035693 | Sheath French Size (F)-5F | 5 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.