Pleural Dynamics, Inc.

FDA Device Registration & Listing · Wayzata, MN, US · Registration 3029300753

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3029300753
FEI Number
3029300753
Entity Name
Pleural Dynamics, Inc.
City/State/Country
Wayzata, MN, US
Establishment Address
952 Medina Road, Wayzata, MN 55391, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Pleural Dynamics, Inc. (Owner Number: 10088649)
Owner / Operator Contact Address
952 Medina Road, Wayzata, MN 55391, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231096
PMA Number
N/A

All Registered Proprietary Names

ACES System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPM Shunt, Peritoneal Gastroenterology, Urology Class 2 876.5955 2023-09-15
GBS Catheter, Ventricular, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2023-09-15

Official Correspondent

John Streeter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pleural Dynamics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0019-2011 Atrium Medical Corporation 1
HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Z-0020-2011 Atrium Medical Corporation 1
HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029300753. Last updated year: 2026. Please use registration number 3029300753 when referencing this establishment in official correspondence.
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