# K901627: Arterial Embolectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Applied Vascular Devices, Inc.
- Decided: Oct 19, 1990 after 193 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
88 later devices descend from it; 2 cite it directly.
4 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960970: Possis Angiojet Rapid Thrombectomy  Catheter System, F105 Catheter,Model 3030C,LF140 Catheter,Model 3040C,Pump Set 3020P (1996), 87 descendants of its own
- K972610: Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040C (2000), 81 descendants of its own
- K040013: Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit (2004), 70 descendants of its own
- K052256: Angiojet Xpeedior 120 Catheter (2005), 68 descendants of its own
- K061951: Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 (2006), 66 descendants of its own

## Recalls of this device
- Aug 9, 2012 · Class II · Z-2446-2012: Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Source page: https://510kreport.com/device/K901627
Methodology: https://510kreport.com/methodology