PARKER FLEX-TIP TRACHEAL TUBE— 510(k) K984528
Substantially EquivalentParker Medical Assoc.
FDA 510(k) clearance K984528 for PARKER FLEX-TIP TRACHEAL TUBE, Substantially Equivalent on 1999-07-15. Applicant: Parker Medical Assoc.. Device class: 2.
Clearance details
- Applicant
- Parker Medical Assoc.
- Product code
- Code BTR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5730
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
Recent devices under product code BTR
view all- K251794 — Tenax® Laser Resistant Endotracheal Tube
- K253437 — Spiro-VISTA
- K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
- K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
- K243579 — AeroJet Ventilation Catheter
Adverse events under product code BTR
product code BTR- Death
- 92
- Injury
- 1,263
- Malfunction
- 7,475
- Other
- 2
- Total
- 8,832
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K984528
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K984528.
Data sourced from openFDA. This site is unofficial and independent of the FDA.