Mallinckrodt Medical Tpi, Inc.
Irvine, CA, US
Mallinckrodt Medical Tpi, Inc. appears in FDA device records in Irvine, CA. FDA records list 4 510(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
- 4
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 4 510(k) clearances for Mallinckrodt Medical Tpi, Inc. between 1993 and 1995. The busiest year on record is 1995, with 2. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K945407 | SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT | BTO | Substantially Equivalent | |
| K945406 | SSV PHONATE(TM) SHILEY SPEAKING VALVE | BTO | Substantially Equivalent | |
| K936224 | REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS | JOH | Substantially Equivalent | |
| K930895 | SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF | JOH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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