Atlas FDA

14F iSLEEVE™ Introducer Set

FDA 510(k) clearance K230051 · decided 2023-02-03

Clearance details

K-number
K230051
Device name
14F iSLEEVE™ Introducer Set
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2023-01-06
Decision date
2023-02-03
Days to decision
28 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

+ Add to Predicate Builder ◉ Watch Boston Scientific Corporation

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) (K261529)Hartman Medical Group, LLC2026-07-06
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

PMA approvals by this applicant

RecordFirmDate
Axonics Sacral Neuromodulation System (P190006/S101)Boston Scientific Corporation2025-12-19
Axonics Sacral Neuromodulation System (P180046/S101)Boston Scientific Corporation2025-12-19
SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S110)Boston Scientific Corporation2025-10-29
Innova™ Vascular Self-Expanding Stent System (P140028/S084)Boston Scientific Corporation2025-10-24
Ranger™ Paclitaxel-Coated PTA Balloon Catheter (P190019/S039)Boston Scientific Corporation2025-10-24
AGENT™ Paclitaxel-Coated Balloon Catheter (P230035/S007)Boston Scientific Corporation2025-10-24
ENROUTE® Transcarotid Stent System (P140026/S032)Boston Scientific Corporation2025-10-23
A209 SICD Gen 2,A219 SICD MRI (P110042/S206)Boston Scientific Corporation2025-10-22