POINT MEDICAL CORP.

FDA Device Registration & Listing · CROWN POINT, IN, US · Registration 1833566

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
1833566
FEI Number
1000115408
Entity Name
POINT MEDICAL CORP.
City/State/Country
CROWN POINT, IN, US
Establishment Address
891 EAST SUMMIT ST., CROWN POINT, IN 46307, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
POINT MEDICAL CORP. (Owner Number: 9002237)
Owner / Operator Contact Address
891 EAST SUMMIT ST., --, Crown Point, IN 46307, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Peritoneal Catheters Subclavian Catheters Long Term Infusion Catheters Hemodialysis Catheters

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2007-11-08
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2007-11-08
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2007-11-08
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2007-11-08

Official Correspondent

Ryan Bentley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

POINT MEDICAL CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K971999 B.Braun Medical, Inc. PERIPHERALLY INSERTED CENTRAL 1997-11-24
K171618 Medcomp (Dba Medical Components, Inc.) Symetrex Long Term Hemodialysis Catheter 2017-11-16
K111817 Covidien PALINDROME RT CHRONIC CATHETER 2011-08-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Z-0004-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0025-2015 Navilyst Medical, Inc 2
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Z-0026-2015 Navilyst Medical, Inc 2
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Z-0027-2015 Navilyst Medical, Inc 2
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1833566. Last updated year: 2026. Please use registration number 1833566 when referencing this establishment in official correspondence.
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