Atlas FDA

RadialSeal Introducer Kit

FDA 510(k) clearance K181855 · decided 2018-07-26

Clearance details

K-number
K181855
Device name
RadialSeal Introducer Kit
Applicant
Great Batch Medical
Decision
Substantially Equivalent
Date received
2018-07-11
Decision date
2018-07-26
Days to decision
15 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Plymouth, MN, US
Third-party review
Yes
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
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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Myopore® Sutureless Myocardial Pacing Lead (P130012/S016)Great Batch Medical2024-04-19
Myopore Sutureless Myocardial Pacing Lead (P130012/S015)Great Batch Medical2023-12-13
Myopore® Sutureless Myocardial Pacing Lead (P130012/S014)Great Batch Medical2023-07-07
Myopore® Sutureless Myocardial Pacing Lead (P130012/S013)Great Batch Medical2023-02-07
Myopore Sutureless Myocardial Pacing Lead (P130012/S010)Great Batch Medical2022-12-12
Myopore® Sutureless Myocardial Pacing Lead (P130012/S009)Great Batch Medical2022-10-05
Myopore Sutureless Myocardial Pacing Lead (P130012/S007)Great Batch Medical2019-07-15
Myopore Sutureless Myocardial Pacing Lead (P130012/S008)Great Batch Medical2019-07-03