Mallinckrodt Medical
ATHLONE Westmeath, IE
Mallinckrodt Medical appears in FDA device records in ATHLONE Westmeath, IE. FDA records list 43 510(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 43 510(k) clearances for Mallinckrodt Medical between 1990 and 2008. The busiest year on record is 1994, with 12. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 4 |
| 1991 | 6 |
| 1992 | 1 |
| 1993 | 4 |
| 1994 | 12 |
| 1995 | 5 |
| 1996 | 4 |
| 1997 | 5 |
| 2005 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082520 | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | |
| K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | JOH | Substantially Equivalent | |
| K972258 | HI-CARE CLOSED SUCTION SYSTEM | BSY | Substantially Equivalent | |
| K971267 | SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF | JOH | Substantially Equivalent | |
| K963732 | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA | JOH | Substantially Equivalent | |
| K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) | CAE | Substantially Equivalent | |
| K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | |
| K962045 | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT | CAH | Substantially Equivalent | |
| K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | JOH | Substantially Equivalent | |
| K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | JOH | Substantially Equivalent | |
| K954749 | MALLINCKRODT SHILEY 15MM CAP | JOH | Substantially Equivalent | |
| K954146 | UTK-DTE AUTILARY SHIELD | KPY | Substantially Equivalent | |
| K953400 | GUEDEL AIRWAY | CAE | Substantially Equivalent | |
| K953295 | ANESTHESIA FACE MASK | BSJ | Substantially Equivalent | |
| K952036 | FLEXLIFE | BYD | Substantially Equivalent | |
| K945513 | MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K943739 | SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER | DQO | Substantially Equivalent | |
| K943276 | WARMTOUCH PLASTIC WARMING COVER | DWJ | Substantially Equivalent | |
| K944124 | SPIROBAC ADAPTERS | CAH | Substantially Equivalent | |
| K942794 | HYGROLIFE | BYD | Substantially Equivalent | |
| K942392 | AIRWAY CONNECTOR WITH FLEX TUBE | BZA | Substantially Equivalent | |
| K941676 | STERIVENT AND STERIVENT S | CAH | Substantially Equivalent | |
| K941585 | HYGROSTER | BYD | Substantially Equivalent | |
| K941536 | BARRIERBAC AND BARRIERBAC S | CAH | Substantially Equivalent | |
| K941535 | TRACHEOLIFE | BYD | Substantially Equivalent | |
| K941381 | HYGROBAC,S HYGROBOY AND HYGROBABY | CAH | Substantially Equivalent | |
| K941246 | RAE II TRACHEAL TUBE | BTR | Substantially Equivalent | |
| K934685 | SOFTTOUCH GUIDE CATHETER | DQY | Substantially Equivalent | |
| K931479 | SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER | DQO | Substantially Equivalent | |
| K932280 | RAE(R) II TRACHEAL TUBE | BTR | Substantially Equivalent | |
| K923538 | MON-A-THERM FOLEY KIT | FCM | Unknown | |
| K922946 | VAPORTEMP HEAT AND MOISTURE EXCHANGER | BYD | Substantially Equivalent | |
| K914887 | ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT | FRQ | Substantially Equivalent | |
| K912199 | SOFTTOUCH(R) GUIDING CATHETER | DQY | Substantially Equivalent | |
| K912191 | SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP | DQY | Substantially Equivalent | |
| K902405 | MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR | CBK | Substantially Equivalent | |
| K905548 | PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE | DQX | Substantially Equivalent | |
| K905547 | SOFTOUCH GUIDING CATHETER | DQY | Substantially Equivalent | |
| K905773 | PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | LIT | Substantially Equivalent | |
| K904212 | HIGH-PRESSURE CONNECTOR TUBE | DXT | Substantially Equivalent | |
| K902317 | PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH. | LIT | Substantially Equivalent | |
| K903330 | MALLINCKRODT MEDICAL, INC., INFUSSION CATHERTER | DQY | Substantially Equivalent | |
| K902953 | SOFTOUCH GUIDING CATHETER | DQO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8020889 | 3003382061 | Mallinckrodt Medical | CORNAMADDY, ATHLONE Westmeath -- IE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAEAirway, Oropharyngeal, Anesthesiology
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- LITCatheter, Angioplasty, Peripheral, Transluminal
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DQYCatheter, Percutaneous
- BSYCatheters, Suction, Tracheobronchial
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- CAHFilter, Bacterial, Breathing-Circuit
- DXTInjector And Syringe, Angiographic
- BSJMask, Gas, Anesthetic
- KPYShield, Protective, Personnel
- BSRStylet, Tracheal Tube
- DWJSystem, Thermal Regulating
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- JOHTube Tracheostomy And Tube Cuff
- BTSTube, Bronchial (W/Wo Connector)
- FRQTube, Levine
- BTRTube, Tracheal (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- CBKVentilator, Continuous, Facility Use
- DQXWire, Guide, 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