# K050630: Pivot Steerable Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific - Precision Vascular
- Decided: Mar 22, 2005 after 11 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960806 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020733: PVS 1500 SDS, Precision Vascular Systems, Inc. (2002) Summary page 1.
- K032494: PVS 1700 Steerable Delivery System Microcatheter, Precision Vascular Systems, Inc. (2003) Summary page 1.
- K033726: PVS Pivot Steerable Delivery System Microcatheter, Precision Vascular (2004) Summary page 1.

## Recalls of this device
- Apr 26, 2006 · Not classified · Z-0895-06: During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.

## Indications for use
The "PivotTM" Steerable Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guidewire exchange/support during diagnostic or interventional procedures.

Source page: https://510kreport.com/device/K050630
Methodology: https://510kreport.com/methodology