← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

PFV — System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.

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

P130029Bard Peripheral Vascular, Inc. · pma2026-06-22
P240023Merit Medical Systems, Inc. · pma2026-06-11
P170042C.R. Bard, Inc. · pma2026-06-10
P130006W. L. Gore & Associates, Inc. · pma2026-05-26

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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