RUSCH ENDOBRONCHIAL TUBE SETS— 510(k) K951091
Substantially EquivalentRusch Intl.
FDA 510(k) clearance K951091 for RUSCH ENDOBRONCHIAL TUBE SETS, Substantially Equivalent on 1995-06-08. Applicant: Rusch Intl.. Device class: 2.
Clearance details
- Applicant
- Rusch Intl.
- Product code
- Code BTS
- Device class
- Class 2
- Regulation
- 21 CFR 868.5720
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jeffrey, NH, US
Recent devices under product code BTS
view allMore clearances from Rusch Intl.
view allAdverse events under product code BTS
product code BTS- Death
- 2
- Malfunction
- 877
- Total
- 879
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 K951091
K-number listed on FDA's recall record- Z-2407-2015 — Bronchial Double Lumen Tube Set (Left), Sterile
- Z-2408-2015 — Bronchial Double Lumen Tube Set (Right), Sterile
- Z-2409-2015 — Bronchial One Lumen Tube - Left
- Z-2410-2015 — Bronchial One Lumen Tube - Right
- Z-2411-2015 — Carlens Bronchial Double Lumen Tube Set (Left) Sterile
- Z-2412-2015 — Tracheopart Set (Left), Sterile
- Z-2413-2015 — Tracheopart Set (Right), Sterile
- Z-2414-2015 — White Bronchial Double Lumen Tube Set (Right) Sterile
- Z-2415-2015 — Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
- Z-1231-2014 — Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951091.
Data sourced from openFDA. This site is unofficial and independent of the FDA.