# K962293: Endosonics Automatic Pull Back Device

- Pathway: 510(k) (Traditional)
- Applicant: Endosonics Corp.
- Decided: Sep 16, 1996 after 94 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 1 cites it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CVIS Catheter Pull-Back Device: named in the summary without a submission number
- (no number) Intertherapy Interpret Catheter Linear Translator: named in the summary without a submission number

## Most influential descendants
- K052348: IN Vision Gold with Spin Vision, Model 891 SV (2005), 29 descendants of its own
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System (2008), 28 descendants of its own
- K082229: S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System (2008), 25 descendants of its own
- K111706: Volcano S5IINTRAVASCULAR Imaging and Pressure System (2011), 24 descendants of its own
- K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System (2013), 21 descendants of its own

## Indications for use
The Endosonics Automatic PBD is intended for use as a pull back accessory to the Endosonics Intravascular Ultrasound Imaging catheters. The Automatic Pull Back Device withdraws the imaging catheter from the vessel through the guide catheter.

Source page: https://510kreport.com/device/K962293
Methodology: https://510kreport.com/methodology