Atlas FDA

14F iSLEEVE Introducer Set

FDA 510(k) clearance K233503 · decided 2023-11-30

Clearance details

K-number
K233503
Device name
14F iSLEEVE Introducer Set
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2023-10-31
Decision date
2023-11-30
Days to decision
30 days
Clearance type
Special
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Maple Grove, MN, 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
Health Line Tearaway Introducer (K261950)Health Line International Corporation2026-06-22
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
Edwards eSheath+ introducer set (K254279)Edwards Lifesciences2026-04-17
Aventus Introducer Sheath (K260091)Inquis Medical2026-04-13
Protaryx Transseptal Puncture Device (PTX2-001) (K260839)Protaryx Medical, Inc.2026-04-10
AuST Steerable Sheath (K260942)CenterPoint Systems, LLC2026-04-07
VANES Delivery System (VDS) (K260459)Zoll Respicardia, Inc.2026-04-06

Recalls involving this device

RecordFirmDate
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral recall (Z-1390-2024)Boston Scientific Corporation2024-03-28

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