# K041630: Orbital Atherectomy System for Treatment of a-V Shunt Stenosis

- Pathway: 510(k) (Abbreviated)
- Applicant: Cardiovascular Systems Incorporated
- Decided: Jan 31, 2005 after 229 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- 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 K901206 (1990). 3 ancestors in all.
30 later devices descend from it; 2 cite it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970080: Arrow-Trerotola PTD Catheter, Arrow Intl., Inc. (1997) Summary page 1.
- K901206: Rotablator, Heart Technology, Inc. (1990) Summary page 1.
- K972357: Blue Max - 20 Balloon Dilatation Catheter, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K071427: Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt Stenosis (2007), 28 descendants of its own
- K071350: Diamondback 360 Degree Orbital Atherectomy System (2007), 28 descendants of its own
- K072748: Modification to: Diamondback 360 Orbital Atherectomy System (2007), 26 descendants of its own
- K081944: Modification to Diamondback 360 Degree Orbital Atherectomy System (2008), 25 descendants of its own
- K090521: Diamondback 360 DBX (2009), 24 descendants of its own

## Indications for use
The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).

Source page: https://510kreport.com/device/K041630
Methodology: https://510kreport.com/methodology