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FDA PRODUCT CODE · CLASS III

PYX — Temporary Non-Roller Type Right Heart Support Blood Pump

Providing temporary partial or full right heart circulatory support.

DEVICE CLASS
Class III
REGULATION
21 CFR 870.4360
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
pma: 1
0
RECALL ENTRIES

Recent clearances

P170011Abiomed, Inc. · pma2026-04-01

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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