BIVONA ENDOTRACHEAL TUBE STYLET— 510(k) K905052
Substantially EquivalentBivona Medical Technologies
FDA 510(k) clearance K905052 for BIVONA ENDOTRACHEAL TUBE STYLET, Substantially Equivalent on 1991-04-02. Applicant: Bivona Medical Technologies. Device class: 1.
Clearance details
- Applicant
- Bivona Medical Technologies
- Product code
- Code BSR
- Device class
- Class 1
- Regulation
- 21 CFR 868.5790
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gary, IN, US
Recent devices under product code BSR
view all- K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
- K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
- K954771 — TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
- K943104 — MOLLOY INTUBATING STYLETTE
- K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
More clearances from Bivona Medical Technologies
view allAdverse events under product code BSR
product code BSR- Death
- 2
- Other
- 1
- Total
- 3
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.