Transtracheal Systems
Denver, CO, US
Transtracheal Systems appears in FDA device records in Denver, CO. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Transtracheal Systems between 1986 and 1999. The busiest year on record is 1991, with 2. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1996 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K982943 | TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 | NFB | Substantially Equivalent | |
| K981078 | TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 | CAW | Substantially Equivalent | |
| K981080 | SCOOP 1 | BTO | Substantially Equivalent | |
| K962944 | TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) | NFB | Substantially Equivalent | |
| K904749 | TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 | DRQ | Substantially Equivalent | |
| K904748 | TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 | DRG | Substantially Equivalent | |
| K902281 | MODIFIED SCOOP TRANSTRACHEAL CATHETERS | BTO | Substantially Equivalent | |
| K854252 | TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER | BTO | Unknown |
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