Company ยท US
Concord/Portex
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1993. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 3 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 3 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 |
| CBT | Arterial Blood Sampling Kit | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 |
| BTS | Tube, Bronchial (W/Wo Connector) | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 |
| BYO | Bottle, Blow | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| EIA | Unit, Operative Dental | 1 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 1 |
| MAJ | Catheter, Percutaneous, Intraspinal, Short Term | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 25, 1993 | K923559 | STERI-CATH MDI Concord/Portex | CAF |
| Jul 27, 1993 | K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES Concord/Portex | MAJ |
| Jul 9, 1993 | K924541 | EPIDURAL MINIPACK Concord/Portex | BYO |
| Jun 22, 1993 | K930286 | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS Concord/Portex | CBT |
| Apr 29, 1993 | K923127 | NEEDLE-PRO CARTRIDGE Concord/Portex | FMI |
| Jan 26, 1993 | K923910 | HEAT MOISTURE CONDENSER Concord/Portex | BYD |
| Sep 2, 1992 | K922749 | LOW PROFILE TRACHEOSTOMY TUBE Concord/Portex | BTO |
| Aug 12, 1992 | K922445 | VACU-PRO Concord/Portex | JKA |
| Feb 14, 1992 | K915452 | ANESTHESIA BREATHING CIRCUIT Concord/Portex | CAI |
| Aug 26, 1991 | K911809 | NEW-VENT Concord/Portex | JKA |
| Aug 16, 1991 | K912124 | TRACHEOSTOMY TUBE AND CUFF Concord/Portex | BTO |
| Jul 5, 1991 | K912043 | ACCU-VENT(TM) WITH NEEDLE-PRO(TM) Concord/Portex | CBT |
| Jun 21, 1991 | K911638 | SYRINGE TIP CAP Concord/Portex | JKA |
| May 3, 1991 | K911037 | SAFETY NEEDLE SHEATH, MODIFICATION Concord/Portex | FMI |
| Jan 31, 1991 | K905011 | ORAL PHARYNGEAL CLEANSING DEVICE Concord/Portex | EIA |
| Dec 19, 1990 | K904198 | SAFETY NEEDLE SHEATH Concord/Portex | FMI |
| Sep 25, 1990 | K903730 | D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES Concord/Portex | BTO |
| Aug 29, 1990 | K902687 | STERI-CATH-DL Concord/Portex | BSY |
| Aug 3, 1990 | K902116 | MODIFIED ENDOBRONCHIAL TUBE Concord/Portex | BTS |
| Jul 12, 1990 | K902383 | STERI-CATH(TM) Concord/Portex | BSY |
| Jan 12, 1990 | K896031 | AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) Concord/Portex | HIO |
| Aug 21, 1989 | K891316 | ANESTHESIA/RESPIRATORY DISPOSABLE MASK Concord/Portex | BSJ |
| Apr 24, 1989 | K892343 | SUCTION CONTROL VALVE Concord/Portex | BSY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||