Atlas FDA

Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)

FDA 510(k) clearance K230283 · decided 2023-03-01

Clearance details

K-number
K230283
Device name
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2023-02-01
Decision date
2023-03-01
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
Sylmar, CA, 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
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
Tendyne™ Transcatheter Mitral Valve System (P240042/S003)ABBOTT MEDICAL2026-08-07
Ampere Generator (P110016/S095)ABBOTT MEDICAL2026-08-07
TactiSys Quartz Equipment; Ampere Generator (P220013/S033)ABBOTT MEDICAL2026-08-07
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S130)ABBOTT MEDICAL2026-07-30
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S259)ABBOTT MEDICAL2026-07-26
Dorsal Root Ganglion (DRG) IPG (P150004/S099)ABBOTT MEDICAL2026-07-26
Deep Brain Stimulation (DBS) IPG (P140009/S138)ABBOTT MEDICAL2026-07-26
Current™ PFA Generator – TactiFlex Duo (P250022/S005)ABBOTT MEDICAL2026-07-23