REPROCESSED HEART STABILIZERS AND POSITIONERS— 510(k) K063844

Name: FDA 510(k) clearance K063844
Creator: U.S. Food and Drug Administration
Published: 2007-03-15

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K063844 for REPROCESSED HEART STABILIZERS AND POSITIONERS, Substantially Equivalent on 2007-03-15. Applicant: Sterilmed, Inc.. Device class: 1.

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code NQG
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 2006-12-26
Decision date: 2007-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQG

view all

K070034 — REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES2007-08-17
K070036 — REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES2007-08-17

More clearances from Sterilmed, Inc.

view all

K254149 — Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825) +3 more2026-06-29
K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter2024-10-11
K190478 — Reprocessed ViewFlex Xtra ICE Catheter2019-11-14
K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology2019-08-15
K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis2019-04-15

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