# K982329: Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900)

- Pathway: 510(k) (Traditional)
- Applicant: Endosonics Corp.
- Decided: Jan 14, 1999 after 196 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have 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).
- (no number) EndoSonics Cathscanner Model 302 Intravascular Imaging Catheter: named in the summary without a submission number
- (no number) Oracle (Cathscanner IIT) Imaging System: named in the summary without a submission number
- (no number) Cook Small Vessel Balloon Angioplasty catheter: named in the summary without a submission number
- (no number) ATL Ultramark 8 imaging system: named in the summary without a submission number
- (no number) Millar Mikro Tip Doppler catheter: named in the summary without a submission number
- (no number) CVIS Insight imaging system and catheters: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K955379: Ibc Gas Cell Components (1/2, 3/8, 1/4), International Biophysics Corp. (1996). Our OCR of the scanned summary read K955379, FDA’s number for Ibc Gas Cell Components (1/2, 3/8, 1/4) (International Biophysics Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “EndoSonics Visions 3.5F model 84700 Intravascular Imaging Catheter”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K071660: Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900 (2007), 4 descendants of its own
- K121273: Visions PV .035 Ditital Ivus Catheter (2012), 3 descendants of its own
- K153094: Visions PV .035 Digital IVUS Catheter (2015), 2 descendants of its own
- K230584: Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (2023), 0 descendants of its own
- K181126: Reprocessed Visions PV .035 Digital IVUS Catheter (2019), 0 descendants of its own

## Indications for use
The Visions catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Visions ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide: (1) An image of the vessel lumen and wall structures. (2) Dimensional measurements from the image.

Source page: https://510kreport.com/device/K982329
Methodology: https://510kreport.com/methodology