Bivona Endotracheal Tube Stylet
FDA 510(k) K905052 · Bivona Medical Technologies
510(k) numberK905052
Submission
- Device name
- Bivona Endotracheal Tube Stylet
- Applicant
- Bivona Medical Technologies
Gary, IN, US - Received
- November 8, 1990
- Decision date
- April 2, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSR – Stylet, Tracheal Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5790
- Specialty
- Anesthesiology
Other 510(k)s with product code BSR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange…BSR · Traditional | Cook Incorporated | 08/11/2017SE |
| K962361 | Trachlight Stylet and Tracheal LightwandBSR · Traditional | Laerdal Medical Corp. | 09/05/1996SE |
| K954771 | Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal…BSR · Traditional | Laerdal Medical Corp. | 05/09/1996SE |
| K943104 | Molloy Intubating StyletteBSR · Traditional | Molloy Corp. | 04/18/1996SE |
| K955238 | Rusch Schroeder Endotracheal Tube StyleBSR · Traditional | Rusch Intl. | 02/06/1996SE |
| K953677 | Lighted Flexguide (Modification)BSR · Traditional | Scientific Sales Intl., Inc. | 08/25/1995SE |
| K952100 | Rusch Endotracheal Tube StyletBSR · Traditional | Rusch, Inc. | 08/08/1995SE |
| K952266 | Schroeder Oral/Nasal Directional StyletteBSR · Traditional | Stebar Instrument Corp. | 06/12/1995SE |
| K950713 | Airguide StyletteBSR · Traditional | Polamedco, Inc. | 05/17/1995SE |
| K950380 | Flextitip StyletteBSR · Traditional | Polamedco, Inc. | 02/10/1995SE |
More from Polamedco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952700 | SuperslickJOH · Traditional | 10/31/1995SE |
| K942025 | Burget Nasal StentLWF · Traditional | 10/27/1995SE |
| K944178 | Bivona Flextend Pediatric & Neonatal Tracheostromy TubesJOH · Traditional | 10/27/1994SE |
| K935053 | Bivona Nasal Turbinate StentLYA · Traditional | 07/01/1994SE |
| K933398 | Bivona Illuminated Endotracheal TubeBTR · Traditional | 10/06/1993SE |
| K931749 | Bivona(R) ICU Endotracheal TubeBTR · Traditional | 08/10/1993SE |
| K922665 | Bivona Hyperflex Tracheostomy TubeJOH · Traditional | 01/07/1993SE |
| K923878 | Bivona Customized Tracheostomy TubesJOH · Traditional | 12/29/1992SE |
| K920604 | Bivona Tracheal T-Tube StentBTO · Traditional | 07/27/1992SE |
| K915761 | Bivona-Colorado Voice ProsthesisEWL · Traditional | 06/29/1992SE |
Questions and answers
When was Bivona Endotracheal Tube Stylet cleared by the FDA?
Bivona Endotracheal Tube Stylet (K905052) received a 510(k) decision of Substantially Equivalent on April 2, 1991, 145 days after the submission was received.
What is the product code of K905052?
The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.