← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

PAR — Test, Volatile Organic Compounds Breath Analysis

Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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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