Atlas FDA

PRELUDE SHORT SHEATH INTRODUCER

FDA 510(k) clearance K082063 · decided 2008-10-15

Clearance details

K-number
K082063
Device name
PRELUDE SHORT SHEATH INTRODUCER
Applicant
Merit Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2008-07-21
Decision date
2008-10-15
Days to decision
86 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
South Jordan, UT, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
NAMIC Dilator and Sheath (K253526)Medline Industries, LP2026-07-29
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SimplGuide (K261242)Pendracare2026-06-25
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FieldFlex Steerable Sheath (K261492)CenterPoint Systems, LLC2026-06-05
Echo Large Bore Introducer Sheath (K260606)Echo Medical, LLC2026-04-29
Introducer Sheath Set (K254248)Cardiocycle Medical(Suzhou) Co., Ltd.2026-04-23
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Recalls involving this device

RecordFirmDate
7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, recall (Z-1497-2017)Merit Medical Systems, Inc.2017-03-24
Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit M recall (Z-0941-2011)Merit Medical Systems, Inc.2011-01-28
Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Pr recall (Z-0517-2010)Merit Medical Systems, Inc.2009-12-14
Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Pr recall (Z-0518-2010)Merit Medical Systems, Inc.2009-12-14
Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, recall (Z-1402-2009)Merit Medical Systems, Inc.2009-06-10
Prelude Short Sheath Introducer, McAlester Regional Hospital - Fistulagram Pack, K12T-0289 recall (Z-1403-2009)Merit Medical Systems, Inc.2009-06-10
5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needl recall (Z-1404-2009)Merit Medical Systems, Inc.2009-06-10
5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide recall (Z-1405-2009)Merit Medical Systems, Inc.2009-06-10
5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No. recall (Z-1406-2009)Merit Medical Systems, Inc.2009-06-10
6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needl recall (Z-1407-2009)Merit Medical Systems, Inc.2009-06-10
6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide recall (Z-1408-2009)Merit Medical Systems, Inc.2009-06-10
6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No: recall (Z-1409-2009)Merit Medical Systems, Inc.2009-06-10
7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needl recall (Z-1410-2009)Merit Medical Systems, Inc.2009-06-10
7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No. recall (Z-1412-2009)Merit Medical Systems, Inc.2009-06-10
8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 7CM Advance Needl recall (Z-1413-2009)Merit Medical Systems, Inc.2009-06-10
8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM, REF N recall (Z-1414-2009)Merit Medical Systems, Inc.2009-06-10
8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No. recall (Z-1415-2009)Merit Medical Systems, Inc.2009-06-10
7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide recall (Z-1647-2009)Merit Medical Systems, Inc.2009-06-10

PMA approvals by this applicant

RecordFirmDate
WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004)Merit Medical Systems, Inc.2025-12-11
WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001)Merit Medical Systems, Inc.2025-02-12
WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002)Merit Medical Systems, Inc.2025-02-12
WRAPSODY® Cell-Impermeable Endoprosthesis (P240023)Merit Medical Systems, Inc.2024-12-19