Data / Medical devices / United States / Footprint Medical Inc.
Footprint Medical Inc.: FDA-registered device maker in San Antonio, TX, United States, 9 510(k) clearances
Footprint Medical Inc. is registered with the FDA (registration 3007697249) in San Antonio, TX, United States. It lists 11 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 3, 2013. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007697249
- Address
- 5823 Sebastian Place, San Antonio, TX, United States, 78249
- Owner or operator
- Footprint Medical Inc. (10029603)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 4, 2009
- Registered through
- 2026
- Brand names listed
- CATHTRAY, DC-PIC, FMI- PICC Introducer, for Peripherally Inserted Central Cather, FMI- Polyurethane Feeding Tube, FMI- Polyurethane PICC, FMI- Polyurethane Umbilical Catheter, FMI- Silicone Dual Lumen Umbilical Catheter, FMI- Silicone Feeding Tube and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Straight | EZD | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Umbilical Artery | FOS | 2 | Manufacturer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Manufacturer | accessdata.fda.gov |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 3, 2013 | K130507 | FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER | LJS | Substantially Equivalent | Footprint Medical, Inc. | accessdata.fda.gov |
| March 1, 2012 | K120304 | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | FOS | Substantially Equivalent | Footprint Medical, Inc. | accessdata.fda.gov |
| November 26, 2010 | K102548 | FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE | KNT | Substantially Equivalent | Footprint Medical, Inc. | accessdata.fda.gov |
| February 24, 2010 | K093026 | FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER | DYB | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
| December 17, 2009 | K093252 | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER | LJS | Substantially Equivalent | Footprint Medical, Inc. | accessdata.fda.gov |
| September 25, 2009 | K091214 | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | FOS | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
| September 25, 2009 | K091213 | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | FOS | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
| August 12, 2009 | K090576 | FOOTPRINT URINARY DRAINAGE CATHETER | EZD | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
| May 4, 2009 | K090559 | FOOTPRINT MEDICAL SILICONE FEEDING TUBE | KNT | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Disposable
- All makers of Catheter, Umbilical Artery
- All makers of Kit, Surgical Instrument, Disposable
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Cutter, Surgical
- All makers of Catheter, Straight
Updated June 3, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.