# K101239: Viewflex Plus Ice Catheter

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jun 2, 2010 after 30 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 1 cites it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K073709: Modification to Viewmate System, Ep Medsystems (2008). Our reading of the summary gave K073709, FDA’s number for Modification to Viewmate System (Ep Medsystems). Its FDA name has none of the distinctive words the summary uses for the device it names, “ViewFlex Plus ICE Catheter”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K121381: Viewflex Xtra Ice Catheter (2012), 15 descendants of its own
- K133853: Viewflex Xtra Ice Catheter (2014), 14 descendants of its own
- K222217: ViewFlex Xtra Reprocessed ICE Catheter (2022), 5 descendants of its own
- K230934: ViewFlex™ Eco Reprocessed ICE Catheter (2023), 4 descendants of its own
- K223077: ViewFlex Xtra ICE Catheter (2022), 4 descendants of its own

## Indications for use
The ViewFleXTM plus ICE Catheter, part of the ViewMate TM System, is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

Source page: https://510kreport.com/device/K101239
Methodology: https://510kreport.com/methodology