Data / Medical devices / Italy / Mallinckrodt Dar S.r.l.
Mallinckrodt Dar S.r.l.: FDA-registered device maker in MIRANDOLA Modena, Italy, 15 510(k) clearances
Mallinckrodt Dar S.r.l. is registered with the FDA (registration 9680661) in MIRANDOLA Modena, Italy. It lists 10 device types. The FDA files 15 510(k) clearances under its listings, the newest dated November 25, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680661
- FEI number
- 3002808696
- Address
- Via G.bove, 2/4/6/8, MIRANDOLA Modena, Italy, 41037
- Owner or operator
- Covidien llc (1282497)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 14, 1991
- Registered through
- 2026
- Brand names listed
- ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT, Airway Connector with Flex Tube, Anesthesia Face Mask, Barrierbac, Barrierbac S, Flexlife, Guedel Airway, HME for Tracheostomized Patients and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer | accessdata.fda.gov |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Manufacturer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheostomy (W/Wo Connector) | BTO | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 25, 2003 | K031997 | MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM | BSY | Substantially Equivalent | Mallinckrodt Dar S.R.L. | accessdata.fda.gov |
| April 19, 2000 | K993268 | MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT | BTT | Substantially Equivalent | Mallinckrodt Dar S.R.L. | accessdata.fda.gov |
| November 26, 1996 | K962045 | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| August 11, 1995 | K953295 | ANESTHESIA FACE MASK | BSJ | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| June 8, 1995 | K952036 | FLEXLIFE | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| February 27, 1995 | K945407 | SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT | BTO | Substantially Equivalent | Mallinckrodt Medical Tpi, Inc. | accessdata.fda.gov |
| February 27, 1995 | K945406 | SSV PHONATE(TM) SHILEY SPEAKING VALVE | BTO | Substantially Equivalent | Mallinckrodt Medical Tpi, Inc. | accessdata.fda.gov |
| September 8, 1994 | K944124 | SPIROBAC ADAPTERS | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| August 22, 1994 | K942794 | HYGROLIFE | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| August 22, 1994 | K942392 | AIRWAY CONNECTOR WITH FLEX TUBE | BZA | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| May 20, 1994 | K941676 | STERIVENT AND STERIVENT S | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 19, 1994 | K941585 | HYGROSTER | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 19, 1994 | K941536 | BARRIERBAC AND BARRIERBAC S | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 15, 1994 | K941535 | TRACHEOLIFE | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 15, 1994 | K941381 | HYGROBAC,S HYGROBOY AND HYGROBABY | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Condenser, Heat And Moisture (Artificial Nose)
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Tube, Tracheostomy (W/Wo Connector)
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Connector, Airway (Extension)
Updated November 25, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.