510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KRDClass II

Device, Vascular, For Promoting Embolization

21 CFR 870.3300 / Cardiovascular
FDA source (opens on fda.gov)

KRD is the FDA product code for Device, Vascular, For Promoting Embolization, a class II device type, regulated under 21 CFR 870.3300. As of , FDA records hold 132 510(k) clearances under this code, the most recent dated , and 19 recalls.

Classification record

Product code
KRD
Device name
Device, Vascular, For Promoting Embolization
Regulation
21 CFR 870.3300
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
132
Ingested recalls
20

Clearances, product code KRD

By decision year
132 clearances under product code KRD with a decision year between 1985 and 2026, 2013 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code KRD by decision year
YearClearances
19851
19881
19891
19921
19942
19961
19971
19991
20001
20031
20042
20053
20064
20072
20085
20094
20103
20115
20128
201311
20147
201511
20164
20174
20184
20196
20204
20213
20228
20232
20246
20259
20266

Applicants with the most clearances

Product code KRD
Applicants holding the most 510(k) clearances under product code KRD
ApplicantClearances
Terumo Cardiovascular Systems Corporation18
Boston Scientific Corporation16
Biosphere Medical, S.A.10
Cook Inc.7
Cook Incorporated6
Vascular Solutions LLC5
Abbott Medical4
BIOCOMPATIBLES U.K. Limited, a BTG Company4
Celonova Biosciences, Inc.4
Medtronic, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 75 companies shown, in name order