CARDIAC ELEVATOR— 510(k) K823094

Name: FDA 510(k) clearance K823094
Creator: U.S. Food and Drug Administration
Published: 1982-12-15

Substantially Equivalent

Cardio Surgical Research, Inc.

FDA 510(k) clearance K823094 for CARDIAC ELEVATOR, Substantially Equivalent on 1982-12-15. Applicant: Cardio Surgical Research, Inc.. Device class: 1.

Clearance details

Applicant: Cardio Surgical Research, Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1982-10-20
Decision date: 1982-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWS

view all

K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 106262002-10-09
K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)1997-01-30
K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS1996-11-19
K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY1996-05-15
K960139 — G.E. STERILE ANGIOGRAPHIC TRAY1996-04-19

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