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Pti Intra-Art Inter Mamm Artery Papaver Infus Kit

by Pioneering Technologies, Inc.

510(k) K883221

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 NumberK883221 Date13 Oct 1988ClearedStatusActive

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  • Withdrawn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
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a catheter, cannula, and tubing assembly designed for vascular use in cardiopulmonary bypass procedures. It is specifically configured for intra-articular infusion of papaverine into the internal mammary artery, facilitating vasodilation or perfusion during surgical interventions.

The kit is intended for single-use in controlled clinical settings, such as operating rooms or cardiac catheterization labs. Supplied sterile and non-reusable, it adheres to FDA 510(k) clearance (K883221) under product code DWF, classified as Class II with special controls. No MRI safety or reusable specifications are noted, and storage conditions align with standard sterile medical device protocols.

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