510(k) K082063 ยท DYB Introducer, Catheter
PRELUDE SHORT SHEATH INTRODUCER
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Oct 15, 2008 |
| Received | Jul 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2021 | Merit Medical Systems, Inc. MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391 Terminated |
DYB | None listed |
| Mar 24, 2017 | Merit Medical Systems, Inc. 7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT.
Produc Usage:
The Merit Prelude Short Sheath Introducer is intended to provide access and facili Terminated |
DYB | None listed |
| Jan 28, 2011 | Merit Medical Systems, Inc. Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah.
Intended to provide access and facilitate the percutaneous introduction of variou Terminated |
DYB | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction o Terminated |
DYB | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introducti Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facilitate the percutaneous intr Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. Prelude Short Sheath Introducer, McAlester Regional Hospital - Fistulagram Pack, K12T-02894C, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facilitate the percutaneous Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-5F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 840 Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire, REF No.: PSS-5F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-5F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facili Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-6F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 840 Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire, REF No.: PSS-6F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No: PSS-6F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facilit Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-7F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 840 Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire; REF No.: PSS-7F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-7F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facili Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 7CM Advance Needle; and 0.018" X 40CM NT/PT Guide Wire; REF No.: PSS-8F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM, REF No.: PSS-8F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and Terminated |
DYB | None listed |
| Jun 10, 2009 | Merit Medical Systems, Inc. 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-8F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
To provide access and facili Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.