# K031810: Amplatzer Vascular Plug

- Pathway: 510(k) (Traditional)
- Applicant: Aga Medical Corp.
- Decided: Sep 9, 2003 after 89 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K891688 (1989). 14 ancestors in all.
38 later devices descend from it; 4 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940189: Coil Positioner Set, Cook, Inc. (1994) Summary page 2.
- K993455: Flipper Detachable Embolization Coil, Cook, Inc. (2000) Summary page 2.
- K955293: Fibered Platinum Coil, .035 Type, Target Therapeutics (1996) Summary page 2.
- K951256: Detachable Platinum Coil (Guglielmi Detachable Coil, GDC), Target Therapeutics (1995) Summary page 2.
- K960705: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 2.
- K962503: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 2.

## Most influential descendants
- K043371: Biomerix Vascular Occlusion Device and Loader (2005), 20 descendants of its own
- K070961: Biomerix Surgical Mesh, Model: RCR-01 (2008), 17 descendants of its own
- K071125: Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 (2007), 16 descendants of its own
- K071699: Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022 (2007), 15 descendants of its own
- K113658: Amplatzer Vascular Plug 4 (2012), 13 descendants of its own

## Recalls of this device
- Sep 1, 2005 · Not classified · Z-0127-06: Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed.

## Indications for use
The AMPLATZER Vascular Plug is indicated for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K031810
Methodology: https://510kreport.com/methodology