SLICK SET— 510(k) K780900
Substantially EquivalentPolamedco, Inc.
FDA 510(k) clearance K780900 for SLICK SET, Substantially Equivalent on 1978-07-17. Applicant: Polamedco, Inc.. Device class: 2.
Clearance details
- Applicant
- Polamedco, Inc.
- 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
- Mchenry, IL, 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
More clearances from Polamedco, Inc.
view allAdverse 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 K780900
K-number listed on FDA's recall record- Z-1827-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
- Z-1828-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
- Z-1829-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
- Z-1830-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065
- Z-1831-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070
- Z-1832-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075
- Z-1833-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080
- Z-1834-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
- Z-1835-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090
- Z-1836-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095
- Z-1837-2023 — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120
- Z-1838-2023 — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125
- Z-1839-2023 — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170130
- Z-1840-2023 — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135
- Z-1841-2023 — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140
- Z-1842-2023 — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145
- Z-1843-2023 — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150
- Z-1844-2023 — Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155
- Z-1860-2023 — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100
- Z-1897-2023 — RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K780900.
Data sourced from openFDA. This site is unofficial and independent of the FDA.