FOOTPRINT MEDICAL INC.

FDA Device Registration & Listing · San Antonio, TX, US · Registration 3007697249

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
3007697249
FEI Number
3007697249
Entity Name
FOOTPRINT MEDICAL INC.
City/State/Country
San Antonio, TX, US
Establishment Address
5823 Sebastian Place, San Antonio, TX 78249, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Footprint Medical Inc. (Owner Number: 10029603)
Owner / Operator Contact Address
5823 Sebastian Place, San Antonio, TX 78249, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

FMI-Silicone Urinary Catheter FMI- Silicone PICC PROBE-UMB CATHTRAY NPT-PIC-NC DC-PIC FMI- Silicone Feeding Tube FMI- Polyurethane Umbilical Catheter Urinary Drainage/Collection Kit FMI-MAXDRAPE Trimmer FOOTPRINT MEDICAL TOURNIQUET FMI- Silicone Dual Lumen Umbilical Catheter FMI- Polyurethane PICC FMI- Silicone Umbilical Catheter FMI- PICC Introducer, for Peripherally Inserted Central Cather

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2010-12-13
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2010-12-13
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2024-03-15
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2015-12-16
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2009-06-04
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2012-12-10
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2015-12-16
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2022-09-26
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2015-12-16
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2017-04-13
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2010-12-13
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2013-08-29
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2010-12-13
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2010-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Footprint Medical Inc.
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
K831798 I M, Inc. DISPOSABLE SCALPELS 1983-07-19
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26
K955248 United States Endoscopy Group, Inc. U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT 1996-05-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2013 Cure Medical LLC 2
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007697249. Last updated year: 2026. Please use registration number 3007697249 when referencing this establishment in official correspondence.
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