# K963989: P.D. Access (Percutaneous Doppler) Vascular Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Dynamics, Inc.
- Decided: Apr 24, 1997 after 202 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: 1 generation back to K851141 (1985). 5 ancestors in all.
2 later devices descend 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.
- K851141: Teleflex Medical Introducer Catheter, Teleflexmedical, Inc. (1985) Summary page 1.

## Cited in the summary but kept off the family tree
- K920208: Urine a Calibrator, Diagnostic Reagents, Inc. (1992). Our OCR of the scanned summary read K920208, FDA’s number for Urine a Calibrator (Diagnostic Reagents, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Over the Needle Splittable Catheter”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K973713: 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car (1998), 1 descendant of its own
- K090743: Yield Mini Doppler System (2009), 0 descendants of its own

## Indications for use
The P.D. Access™ / SmartNeedle® Device is indicated and intended for general vascular use for monitoring the flow of blood within the vasculature.

Source page: https://510kreport.com/device/K963989
Methodology: https://510kreport.com/methodology