EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116— 510(k) K881449

Name: FDA 510(k) clearance K881449
Creator: U.S. Food and Drug Administration
Published: 1988-06-15

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K881449 for EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116, Substantially Equivalent on 1988-06-15. Applicant: Baxter Healthcare Corp. Device class: 1.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code LXN
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1988-04-05
Decision date: 1988-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LXN

view all

K890165 — FORCEPS-ORTHOPEDIC1989-02-13

More clearances from Baxter Healthcare Corp

view all

K190910 — PrisMax System Version 22019-07-25
K163530 — PrisMax Control Unit2017-05-03
K130531 — ULTRAFUSE2014-04-08
K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS2013-10-08
K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO2013-03-01

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