EXACTA PERCUTANEOUS INTRODUCER SHEATH— 510(k) K941428

Name: FDA 510(k) clearance K941428
Creator: U.S. Food and Drug Administration
Published: 1994-07-06

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K941428 for EXACTA PERCUTANEOUS INTRODUCER SHEATH, Substantially Equivalent on 1994-07-06. Applicant: Ohmeda Medical. Device class: 2.

Clearance details

Applicant: Ohmeda Medical
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 1994-03-24
Decision date: 1994-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxnard, 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 Ohmeda Medical

view all

K123309 — GIRAFFE AND PANDA WARMERS2013-02-05
K101778 — GIRAFFE INCUBATOR2010-07-21
K101788 — GIRAFFE OMNIBED2010-07-21
K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER2009-04-16
K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)2007-08-27

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.