# K033726: PVS Pivot Steerable Delivery System Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Precision Vascular
- Decided: Jan 16, 2004 after 49 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960806 (1996). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K050630: Pivot Steerable Microcatheter (2005), 0 descendants of its own

## Indications for use
The PVS "PivotTM" Steerable Delivery System® 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/K033726
Methodology: https://510kreport.com/methodology