510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K071125Substantially Equivalent

Amplatzer Vascular Plug II Models: Avp2-004, Avp2-006, Avp2-008, Avp2-010, Avp2-012, Avp2-014, Avp2-016

Abbott Medical, Plymouth MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071125 is the FDA 510(k) clearance record for AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016, a class II device, cleared for Aga Medical Corp. on under FDA product code KRD (Device, Vascular, For Promoting Embolization). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K071125.

Clearance record

Decision date
Received
(56 days to decision)
Product code
KRD Device, Vascular, For Promoting Embolization
Regulation
21 CFR 870.3300
Device class
Class II
Review panel
Cardiovascular
Applicant
Aga Medical Corp. 5050 Nathan Ln. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRD

Trailing 12 months
8 clearances under product code KRD in the twelve months to November 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRD, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20262
August 20260
September 20260
October 20261
November 20260