PARKER FLEX-TIP TRACHEAL TUBE
FDA 510(k) clearance K984528 · decided 1999-07-15
Clearance details
- K-number
- K984528
- Device name
- PARKER FLEX-TIP TRACHEAL TUBE
- Applicant
- Parker Medical Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-21
- Decision date
- 1999-07-15
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with recall (Z-1399-2017) | Parker Medical | 2017-03-03 |