Company ยท US
Rex Medical
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2021. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 8 |
| DYB | Introducer, Catheter | 4 |
| DTK | Filter, Intravascular, Cardiovascular | 3 |
| MSD | Catheter, Hemodialysis, Implanted | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 1 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2021 | K212351 | Revolution Peripheral Atherectomy System Rex Medical, L.P. | MCW |
| Sep 12, 2019 | K191419 | Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire Rex Medical, L.P. | MCW |
| Jan 30, 2018 | K173389 | Rex Medical Aspiration Pump Rex Medical, L.P. | BTA |
| Apr 16, 2015 | K143405 | Option (TM) ELITE Vena Cava Filter 100cm System Rex Medical, L.P. | DTK |
| Nov 14, 2014 | K141617 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM Rex Medical, L.P. | QEW |
| Dec 17, 2013 | K133243 | OPTION ELITE VENA CAVA FILTER SYSTEM Rex Medical, L.P. | DTK |
| Jun 1, 2012 | K120346 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM Rex Medical | MCW |
| May 22, 2012 | K113103 | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE Rex Medical | PNO |
| Nov 18, 2010 | K102043 | ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER Rex Medical | MSD |
| Feb 18, 2010 | K091029 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) Rex Medical | MCW |
| Jun 4, 2009 | K081410 | OPTION VENA CAVA FILTER Rex Medical | DTK |
| Aug 22, 2007 | K071422 | 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET Rex Medical | MSD |
| Apr 28, 2006 | K060904 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM Rex Medical, L.P. | MCW |
| Aug 4, 2005 | K051468 | INNER-LOCK INTRODUCER SHEATH Rex Medical | DYB |
| Dec 17, 2004 | K042399 | MODIFICATION TO SHORT INTRODUCER SHEATH Rex Medical, L.P. | DYB |
| Feb 26, 2004 | K040252 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT Rex Medical | MCW |
| Dec 16, 2003 | K033793 | CLEANER II ROTATIONAL THROMBECTOMY SYSTEM Rex Medical | MCW |
| Sep 16, 2003 | K032569 | SHORT INTRODUCER SHEATH Rex Medical | DYB |
| May 27, 2003 | K031610 | REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM Rex Medical | MCW |
| Apr 30, 2003 | K023847 | HEMO-STREAM HEMODIALYSIS CATHETER SET Rex Medical | MSD |
| Jan 21, 2003 | K022170 | INNER-LOCK LOCKING INTRODUCER SHEATHS Rex Medical | DYB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||