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Amplatzer Vascular Plug Ii (Avp2-003 +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071699

by Aga Medical Corp.

Identifiers

510(k) Number
K071699 FDA 510(k)
FDA Product Code
KRD FDA 510(k)
Models / Variants
Avp2-003 FDA 510(k)
Avp2-018 FDA 510(k)
Avp2-020 FDA 510(k)
Avp2-022 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3300 FDA 510(k)
Regulation Number
870.3300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Amplatzer Vascular Plug Ii (Avp2-003 +3 more) by Aga Medical Corp. — Class II — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aga Medical Corp.

Sources (1)

  • FDA 510(k) K071699 24 fields · synced Jun 18, 2026