IntriCon Corporation VH

FDA Device Registration & Listing · Vadnais Heights, MN, US · Registration 3007939342

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
3007939342
FEI Number
3007939342
Entity Name
IntriCon Corporation VH
City/State/Country
Vadnais Heights, MN, US
Establishment Address
4400 McMenemy St, Vadnais Heights, MN 55127, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
INTRICON CORPORATION (Owner Number: 9039676)
Owner / Operator Contact Address
1265 Grey Fox Road, --, Saint Paul, MN 55112, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-12-10
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2015-12-10
LZG Pump, Infusion, Insulin General Hospital Class 2 880.5725 2015-12-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-12-10
MDS Sensor, Glucose, Invasive Unknown Class 3 N/A 2013-12-20
OZO Automated Insulin Dosing , Threshold Suspend Unknown Class 3 N/A 2013-12-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-12-10
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2015-12-10
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-11
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-01-11
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2013-01-11
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INTRICON CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014498598 IntriCon Corporation Grey Fox Arden Hills, MN, US
2134850 INTRICON CORPORATION ARDEN HILLS, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007939342. Last updated year: 2026. Please use registration number 3007939342 when referencing this establishment in official correspondence.
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