Footprint Medical Inc.
San Antonio, TX, US
FOOTPRINT MEDICAL INC. appears in FDA device records in San Antonio, TX. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Footprint Medical Inc. between 2009 and 2013. The busiest year on record is 2009, with 6. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 6 |
| 2010 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130507 | FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER | LJS | Substantially Equivalent | |
| K120304 | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | FOS | Substantially Equivalent | |
| K102548 | FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE | KNT | Substantially Equivalent | |
| K093026 | FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER | DYB | Substantially Equivalent | |
| K093252 | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER | LJS | Substantially Equivalent | |
| K091214 | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | FOS | Substantially Equivalent | |
| K091213 | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | FOS | Substantially Equivalent | |
| K091488 | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C | LJS | Substantially Equivalent | |
| K090576 | FOOTPRINT URINARY DRAINAGE CATHETER | EZD | Substantially Equivalent | |
| K090559 | FOOTPRINT MEDICAL SILICONE FEEDING TUBE | KNT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007697249 | 3007697249 | FOOTPRINT MEDICAL INC. | 5823 Sebastian Place, San Antonio, TX 78249 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- EZDCatheter, Straight
- FOSCatheter, Umbilical Artery
- FZTCutter, Surgical
- PUIDrape, Surgical, Exempt
- KDCInstrument, Surgical, Disposable
- DYBIntroducer, Catheter
- KDDKit, Surgical Instrument, Disposable
- GAXTourniquet, Nonpneumatic
- KNTTubes, Gastrointestinal (And Accessories)
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain