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

Introducer, Catheter

21 CFR 870.1340 / Cardiovascular
FDA source (opens on fda.gov)

DYB is the FDA product code for Introducer, Catheter, a class II device type, regulated under 21 CFR 870.1340. As of , FDA records hold 706 510(k) clearances under this code, the most recent dated , and 389 recalls.

Classification record

Product code
DYB
Device name
Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
706
Ingested recalls
389

Clearances, product code DYB

By decision year
706 clearances under product code DYB with a decision year between 1977 and 2026, 2014 the highest year at 30.
Show the numbers
510(k) clearances under FDA product code DYB by decision year
YearClearances
19776
19782
19798
19805
19817
19828
19834
198412
198515
198614
198714
19887
198915
199017
199115
199214
199320
19948
199512
199615
199712
199812
19996
200017
200119
200215
200315
200413
200515
200612
200712
200817
200914
201018
201117
201222
201326
201430
201517
201619
201724
201819
201918
20209
202112
202213
202315
202418
202516
202616

Applicants with the most clearances

Product code DYB
Applicants holding the most 510(k) clearances under product code DYB
ApplicantClearances
Merit Medical Systems, Inc.36
Abbott Medical34
Terumo Medical Corp.27
Cordis US Corp.23
Boston Scientific Corporation20
Greatbatch Medical18
Cook Incorporated17
C.R. Bard Inc16
Daig Corp.16
Edwards Lifesciences LLC15

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 211 companies shown, in name order