# K973713: 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Dynamics, Inc.
- Decided: Jan 23, 1998 after 116 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K851141 (1985). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903625: Doppler Needle and Flow Monitor, Peripheral Systems Group (1990) Summary page 1.
- K913746: Smartneedle (TM) Vascular Access System, Peripheral Systems Group (1991) Summary page 1.
- K913941: PSG (TM) 20 Guage Doppler Needle, Peripheral Systems Group (1992) Summary page 1.
- K940804: Smartneedle Vascular Access System, Modification, Peripheral Systems Group (1994) Summary page 1.
- K963989: P.D. Access (Percutaneous Doppler) Vascular Access Device, Cardiovascular Dynamics, Inc. (1997) Summary page 1.
- K851141: Teleflex Medical Introducer Catheter, Teleflexmedical, Inc. (1985) Summary page 1.

## Most influential descendants
- K090743: Yield Mini Doppler System (2009), 0 descendants of its own

## Indications for use
P.D. Access Device: is intended for use when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and introducer of this size or larger These additional probe/needle models are being incorporated to broaden the product line in order to accommodate both user preference and patient anatomies for all age groups. P.D. Access Monitor: Is intended for use to audibly indicate the doppler response of blood flow within an artery or vein. It is intended for use only in conjunction with the P.D. Access Vascular Access Device. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K973713
Methodology: https://510kreport.com/methodology