Concord/Portex
Keene, NH, US
Concord/Portex appears in FDA device records in Keene, NH. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Concord/Portex between 1989 and 1993. The busiest year on record is 1990, with 6. The most recent is 1993, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1990 | 6 |
| 1991 | 6 |
| 1992 | 3 |
| 1993 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K923559 | STERI-CATH MDI | CAF | Substantially Equivalent | |
| K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | MAJ | Substantially Equivalent | |
| K924541 | EPIDURAL MINIPACK | BYO | Unknown | |
| K930286 | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | CBT | Unknown | |
| K923127 | NEEDLE-PRO CARTRIDGE | FMI | Substantially Equivalent | |
| K923910 | HEAT MOISTURE CONDENSER | BYD | Substantially Equivalent | |
| K922749 | LOW PROFILE TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | |
| K922445 | VACU-PRO | JKA | Substantially Equivalent | |
| K915452 | ANESTHESIA BREATHING CIRCUIT | CAI | Substantially Equivalent | |
| K911809 | NEW-VENT | JKA | Substantially Equivalent | |
| K912124 | TRACHEOSTOMY TUBE AND CUFF | BTO | Substantially Equivalent | |
| K912043 | ACCU-VENT(TM) WITH NEEDLE-PRO(TM) | CBT | Unknown | |
| K911638 | SYRINGE TIP CAP | JKA | Substantially Equivalent | |
| K911037 | SAFETY NEEDLE SHEATH, MODIFICATION | FMI | Substantially Equivalent | |
| K905011 | ORAL PHARYNGEAL CLEANSING DEVICE | EIA | Substantially Equivalent | |
| K904198 | SAFETY NEEDLE SHEATH | FMI | Substantially Equivalent | |
| K903730 | D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES | BTO | Substantially Equivalent | |
| K902687 | STERI-CATH-DL | BSY | Substantially Equivalent | |
| K902116 | MODIFIED ENDOBRONCHIAL TUBE | BTS | Substantially Equivalent | |
| K902383 | STERI-CATH(TM) | BSY | Substantially Equivalent | |
| K896031 | AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) | HIO | Substantially Equivalent | |
| K891316 | ANESTHESIA/RESPIRATORY DISPOSABLE MASK | BSJ | Substantially Equivalent | |
| K892343 | SUCTION CONTROL VALVE | BSY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CBTArterial Blood Sampling Kit
- BYOBottle, Blow
- MAJCatheter, Percutaneous, Intraspinal, Short Term
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BSJMask, Gas, Anesthetic
- CAFNebulizer (Direct Patient Interface)
- FMINeedle, Hypodermic, Single Lumen
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- BTSTube, Bronchial (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- EIAUnit, Operative Dental
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain