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

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Unknown
FDA source (opens on fda.gov)

NIK is the FDA product code for Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D), a class III device type. FDA's definition for this code reads: "These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy". As of , FDA records hold no 510(k) clearances under this code and 153 recalls.

Classification record

Product code
NIK
Device name
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA definition
These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
153

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order