AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002— 510(k) K090867

Name: FDA 510(k) clearance K090867
Creator: U.S. Food and Drug Administration
Published: 2009-07-30

Substantially Equivalent

Ep Dynamics, Inc.

FDA 510(k) clearance K090867 for AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002, Substantially Equivalent on 2009-07-30. Applicant: Ep Dynamics, Inc.. Device class: 2.

Clearance details

Applicant: Ep Dynamics, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2009-03-31
Decision date: 2009-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission Viejo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYB

view all

K253526 — NAMIC Dilator and Sheath2026-07-29
K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more2026-07-06
K261242 — SimplGuide2026-06-25
K261950 — Health Line Tearaway Introducer2026-06-22
K261492 — FieldFlex Steerable Sheath2026-06-05

More clearances from Ep Dynamics, Inc.

view all

K111603 — LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM2012-08-23

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.