Company ยท US
Rusch Intl.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2003. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 7 |
| JOH | Tube Tracheostomy And Tube Cuff | 5 |
| EZL | Catheter, Retention Type, Balloon | 4 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 |
| ESW | Prosthesis, Esophageal | 2 |
| FEN | Device, Cystometric, Hydraulic | 2 |
| KOD | Catheter, Urological | 2 |
| NYT | Prosthesis, Tracheal, Expandable, Polymeric | 2 |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 |
| BSR | Stylet, Tracheal Tube | 1 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 |
| BTS | Tube, Bronchial (W/Wo Connector) | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 |
| CAZ | Anesthesia Conduction Kit | 1 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 1 |
| FAD | Stent, Ureteral | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2003 | K033023 | INTERMITTENT URETHRAL CATHETERS Rusch Intl. | KOD |
| Jun 30, 2003 | K030559 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM Rusch Intl. | ESW |
| Jun 17, 2003 | K023666 | RUSCH GUIDED CHOLANGIOGRAPHY CATHETER Rusch Intl. | FGE |
| Mar 28, 2003 | K023918 | RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS Rusch Intl. | JOH |
| Dec 23, 2002 | K023964 | RUSCH MICROLARYNGEAL TUBE Rusch Intl. | BTR |
| Aug 1, 2002 | K021540 | RUSCH EDGAR TUBE Rusch Intl. | BTR |
| Jul 23, 2002 | K021764 | RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED Rusch Intl. | BTO |
| Jul 1, 2002 | K020714 | RUSCH FLONEIL; FLOCATH INTROGEL Rusch Intl. | GBM |
| Feb 26, 2002 | K010798 | RUSCH CANTOR TUBE Rusch Intl. | KNT |
| Feb 26, 2002 | K010797 | RUSCH MILLER-ABBOTT TUBE Rusch Intl. | KNT |
| Feb 12, 2002 | K013872 | RUSCH MEMORY BAG Rusch Intl. | GCJ |
| Nov 27, 2001 | K013266 | RUSCH POLYFLEX STENT KIT Rusch Intl. | NYT |
| Nov 21, 2001 | K010596 | RUSCH BRONCHUS BLOCKER KIT Rusch Intl. | CBI |
| Nov 16, 2001 | K011122 | BALLPEN SPINAL NEEDLE W/WO INTRODUCER Rusch Intl. | BSP |
| Nov 16, 2001 | K011121 | RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS Rusch Intl. | LJE |
| Aug 15, 2001 | K011210 | THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY Rusch Intl. | JOH |
| Feb 8, 2001 | K010068 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM Rusch Intl. | ESW |
| Feb 18, 2000 | K000070 | FLOCATH Rusch Intl. | KOD |
| Feb 2, 2000 | K993786 | RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY Rusch Intl. | BTR |
| Dec 9, 1999 | K993063 | RUSCH BRILLANT SILICONE FOLEY Rusch Intl. | EZL |
| Aug 3, 1999 | K990619 | RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE Rusch Intl. | BTR |
| Jul 2, 1999 | K982974 | DD URETERAL STENT, INTEGRAL STENT Rusch Intl. | FAD |
| Feb 12, 1999 | K983010 | SELF CATH SET/SAFETY CATH Rusch Intl. | FCM |
| Dec 4, 1998 | K982614 | RUSCH POLYFLEX STENT KIT Rusch Intl. | NYT |
| Nov 17, 1998 | K983125 | EPIDURAL CATHETER MODELS 1210/1200 Rusch Intl. | CAZ |
| Jun 5, 1998 | K981203 | RUSCH BLAKEMORE 3 LUMEN, STERILE Rusch Intl. | KNT |
| May 18, 1998 | K973892 | RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE) Rusch Intl. | KNT |
| Apr 14, 1998 | K972546 | RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET Rusch Intl. | JOH |
| Feb 13, 1998 | K972423 | RUSCH TRACHEOFIX-SET Rusch Intl. | JOH |
| Jan 8, 1998 | K972184 | RUSCH BRILLANT SILICONE FOLEY CATHETER Rusch Intl. | EZL |
| Oct 10, 1997 | K964056 | RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE Rusch Intl. | JOH |
| Oct 7, 1997 | K971643 | RUSCH BRILLANT BALLOON CATHETER Rusch Intl. | EZL |
| Feb 4, 1997 | K964575 | SYMPACATH HYDROGEL COATED FOLEY Rusch Intl. | EZL |
| Aug 27, 1996 | K962472 | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER Rusch Intl. | FAP |
| Aug 16, 1996 | K961837 | RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY Rusch Intl. | BTR |
| Jun 27, 1996 | K961840 | RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY Rusch Intl. | BTR |
| May 10, 1996 | K954585 | RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE Rusch Intl. | BTR |
| Apr 19, 1996 | K960240 | RUSCH OPTOSAFE Rusch Intl. | CAE |
| Feb 6, 1996 | K955238 | RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE Rusch Intl. | BSR |
| Jun 15, 1995 | K952573 | RUSCH URODYNAMIC RECTAL BALLOON CATHETER Rusch Intl. | FEN |
| Jun 13, 1995 | K952029 | RUSCH INTERNATIONAL URODYNAMIC CATHETERS Rusch Intl. | FEN |
| Jun 8, 1995 | K951091 | RUSCH ENDOBRONCHIAL TUBE SETS Rusch Intl. | BTS |
| Apr 6, 1995 | K951046 | RUSCH ENDOTEST CUFF PRESSURE MONITOR Rusch Intl. | BSK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||