← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

PSQ — Intracardiac Patch Or Pledget, Biologically Derived

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

DEVICE CLASS
Class II
REGULATION
21 CFR 870.3470
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
✓ 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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