# K964061: Gore Angioscopic Valvvlotome Kit (TBD)

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Feb 20, 1997 after 133 days
- Product code: LYK (Angioscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923996 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930011: Uresil Valve Cutter with Interchangeable Heads, Uresil Corp. (1993) Summary page 1.
- K923996: Disposable Vascular Angioscope, Endovascular, Inc. (1993) Summary page 1.
- (no number) GORE Irrigation System: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K900894: Medilase Series 2100 Endoscope, Medical Laser, Inc. (1990). Our OCR of the scanned summary read K900894, FDA’s number for Medilase Series 2100 Endoscope (Medical Laser, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CLARUS Angioscope”. Kept off the family tree. Summary page 1.

## Indications for use
The angioscopic valvulotome kit is intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass.

Source page: https://510kreport.com/device/K964061
Methodology: https://510kreport.com/methodology