EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000— 510(k) K022071

Clearance details

Applicant

Embol-X, Inc.

Product code

Code DTM

Device class

Class 2

Regulation

21 CFR 870.4260

Advisory panel

Cardiovascular

Date received

2002-06-26

Decision date

2003-02-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mountain View, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022071.