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510(k) K090867

Device
AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002
Applicant
EP DYNAMICS, INC.
510(k) number
K090867
Product code
DYB  
Decision
Substantially Equivalent (SESE)
Decision date
2009-07-30
Date received
2009-03-31
Regulation
870.1340
Classification name
Introducer, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ALBERT REGO
Address
27001 La Paz #314 Mission Viejo CA US 92691 92691

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DYB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260606Echo Large Bore Introducer SheathEcho Medical, LLC2026-04-29
K254248Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.2026-04-23
K254279Edwards eSheath+ introducer setEdwards Lifesciences2026-04-17
K260091Aventus Introducer SheathInquis Medical2026-04-13
K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc.2026-04-10
K260942AuST Steerable SheathCenterPoint Systems, LLC2026-04-07
K260459VANES Delivery System (VDS)Zoll Respicardia, Inc.2026-04-06
K260626Multiflex Steerable Sheath 17.5FVizaramed, Inc.2026-03-26
K260163AuST CSP IntroducerCenterPoint Systems, LLC2026-02-19
K254236Peel-Away Introducer SheathVascuTech Medical, LLC2026-02-09
K253652Genie MAX Large Bore Introducer SheathCultiv8 1, LLC2026-01-22
K252508Intri26 Introducer SheathInari Medical, Inc.2025-12-17
K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc.2025-12-15
K252309PerQseal IntroducersVivasure Medical Limited2025-10-23
K251838Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.2025-10-21

Legacy Summary#

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FDA Review#

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