← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

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

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
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
✓ Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
pma: 4
0
RECALL ENTRIES

Recent clearances

P010031Medtronic Cardiac Rhythm Disease Management · pma2026-07-16
P030054ABBOTT MEDICAL · pma2026-07-09
P010012Boston Scientific Corp · pma2026-07-01
P060027MicroPort CRM USA, Inc. · pma2025-11-25

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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