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

Catheter, Flow Directed

21 CFR 870.1240 / Cardiovascular
FDA source (opens on fda.gov)

DYG is the FDA product code for Catheter, Flow Directed, a class II device type, regulated under 21 CFR 870.1240. As of , FDA records hold 99 510(k) clearances under this code, the most recent dated , and 49 recalls.

Classification record

Product code
DYG
Device name
Catheter, Flow Directed
Regulation
21 CFR 870.1240
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
99
Ingested recalls
49

Clearances, product code DYG

By decision year
99 clearances under product code DYG with a decision year between 1976 and 2024, 1982 the highest year at 17.
Show the numbers
510(k) clearances under FDA product code DYG by decision year
YearClearances
19761
19775
19781
19804
19816
198217
19838
198413
19854
19861
19872
19881
19894
19903
19913
19933
19944
19951
19961
19973
19991
20002
20011
20021
20081
20111
20161
20201
20221
20231
20243

Applicants with the most clearances

Product code DYG
Applicants holding the most 510(k) clearances under product code DYG
ApplicantClearances
Baxter Healthcare Corporation7
Nova Medical Specialties7
American Edwards Laboratories6
Edwards Lifesciences LLC5
C.R. Bard Inc4
J-Lloyd Medical, Inc.4
Medtronic, Inc.4
Critikon Company, LLC3
Instrumentation Laboratory Co.3
Parke-Davis Co.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order