# K990823: PVS 1400 Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Precision Vascular Systems, Inc.
- Decided: Jul 23, 1999 after 133 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K873543 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881897: Acs HI-Torque Floppy/Floppy II/Inter./Standard GW, Advanced Cardiovascular Systems, Inc. (1988) Summary page 2.
- K910280: Ultra-Select Ptca Guidewire, Microvena Corp. (1991) Summary page 2.
- K873543: Stubbie Steerable Guidewire, Target Therapeutics (1987) Summary page 2.
- K953760: Cordis Wizdom Steerable Guidewire, Cordis Corp. (1995) Summary page 2.

## Indications for use
These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature

Source page: https://510kreport.com/device/K990823
Methodology: https://510kreport.com/methodology