# K160747: Angel Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bio2 Medical, Inc.
- Decided: Jul 28, 2016 after 132 days
- Product code: PNS (Short-Term Intravascular Filter Catheter)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 48 ancestors in all.
No later device cites it as a predicate yet.
6 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073374: Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set, William Cook Europe Aps (2008) Summary page 5.
- K093659: Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian Delivery Kit Model RF500F Model RF5, C.R. Bard, Inc. (2010) Summary page 5.
- K091709: Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC, Edwards Lifesciences, LLC (2009) Summary page 5.
- K962577: Arrowgard Blue Quad-Lumen Central Venous Catheter, Arrow Intl., Inc. (1997) Summary page 5.

## Indications for use
The Angel® Catheter is intended to provide the combined functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter. The Angel® Catheter is intended for short term use for the prevention of clinically significant pulmonary embolism (PE) in critically ill patients at high risk for PE or recurrent PE, and recognized contraindications to standard pharmacological thromboprophylaxis therapy. The Angel® Catheter is also intended to provide access to the central venous system.

Source page: https://510kreport.com/device/K160747
Methodology: https://510kreport.com/methodology