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P.D. Access (Percutaneous Doppler) Vascular Access Device

by Cardiovascular Dynamics, Inc.

510(k) K963989

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963989 Date24 Apr 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The P.D. Access (Percutaneous Doppler) Vascular Access Device is a vascular access device designed for general vascular use to monitor the flow of blood within the vasculature. It is intended to be used in conjunction with the SmartNeedle® Monitor for vascular flow monitoring.

The device is supplied as a reusable vascular access tool and is indicated for use in clinical settings requiring vascular monitoring. It received FDA 510(k) clearance (K963989) on April 24, 1997, as substantially equivalent to predicate devices, and is manufactured by Cardiovascular Dynamics, Inc. in Irvine, California.

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